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Home » FDA releases December 510(k) clearances

FDA releases December 510(k) clearances

January 10, 2011 By MassDevice staff

FDA logo

December 2010 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL

DECISIONS RENDERED DURING THE PERIOD December 2010



DEVICE: V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40

VALERITAS, LLC                    510(k) NO: K100504(TRADITIONAL)

ATTN: SCOTT  HUIE                 PHONE NO : 508 845 8744   

800 BOSTON TURNPIKE               SE DECISION MADE: 01-DEC-10

SHREWSBURY MA 01545               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CCPOINT

EURO-DIAGNOSTICA AB               510(k) NO: K093908(TRADITIONAL)

ATTN: ROBERT  SCHIFF              PHONE NO : 973 227 1830   

1129 BLOOMFIELD AVENUE            SE DECISION MADE: 01-DEC-10

WEST CALDWELL NJ 07006            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET

OVESCO ENDOSCOPY AG               510(k) NO: K101428(TRADITIONAL)

ATTN: ARNE  BRIEST                PHONE NO : 497 214 764847

KASTELLSTR. 8 BADEN WUERTTEMBERG  SE DECISION MADE: 01-DEC-10

KARLSRUHE    GM 76227             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130

LIFELINE SYSTEMS, INC.            510(k) NO: K103214(SPECIAL)

ATTN: CARLOS O ACOSTA             PHONE NO : 508 988 1366   

111 LAWRENCE ST.                  SE DECISION MADE: 01-DEC-10

FRAMINGHAM MA 01702 8156          510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SL3

DISCUS DENTAL, LLC                510(k) NO: K102639(SPECIAL)

ATTN: CLARK D VONAHSEN            PHONE NO : 310 845 8216   

8550 HIGUERA ST.                  SE DECISION MADE: 01-DEC-10

CULVER CITY CA 90232              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LLX240AB01

SAMSUNG MOBILE DISPLAY CO., LTD   510(k) NO: K102587(TRADITIONAL)

ATTN: DAVE  KIM                   PHONE NO : 832 623 2099   

333 MEADOWLANDS PKWY #303         SE DECISION MADE: 01-DEC-10

SECAUCUS NJ 07094                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: HEPARIN ASSAY CONTROLS

MEDTRONIC INC.                    510(k) NO: K103313(SPECIAL)

ATTN: JEFFREY L KOLL              PHONE NO : 763 514 9842   

8200 CORAL SEA STREET NE          SE DECISION MADE: 01-DEC-10

MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: TOMOPHASE OCTIS

TOMOPHASE CORPORATION             510(k) NO: K102599(TRADITIONAL)

ATTN: DEREK  BEAUPRE              PHONE NO : 603 264 3831   

14 BURGUNDY DRIVE                 SE DECISION MADE: 01-DEC-10

HAMPTON NH 03842                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM

NUVASIVE, INC.                    510(k) NO: K102514(SPECIAL)

ATTN: ELISA  KETCHUM              PHONE NO : 858 320 4588   

7475 LUSK BLVD                    SE DECISION MADE: 01-DEC-10

SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: VITALA CONTINENCE CONTROL DEVICE

CONVATEC INC                      510(k) NO: K102536(TRADITIONAL)

ATTN: CHARLES  RYAN               PHONE NO : 908 904 2500   

200 HEADQUARTERS PARK DRIVE       SE DECISION MADE: 01-DEC-10

SKILLMAN NJ 08558                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BRAVO PH MONITORING SYSTEM AND ACCESSORIES

GIVEN IMAGING LTD.                510(k) NO: K102543(TRADITIONAL)

ATTN: TIM  THOMAS                 PHONE NO : 972 490 97936

P.O. BOX 258 NEW INDUSTRIAL PARK  SE DECISION MADE: 01-DEC-10

YOQNEAM    IS 20692               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CONCORDE CURVE SYSTEM

DEPUY SPINE                       510(k) NO: K101923(SPECIAL)

ATTN: EUGENE  BANG                PHONE NO : 508 977 3966   

325 PARAMOUNT DR.                 SE DECISION MADE: 01-DEC-10

RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SLEEK OTW PTA CATHETERS

CLEAR STREAM TECHNOLOGIES, LTD.   510(k) NO: K102035(SPECIAL)

ATTN: FIONA  NI MHULLAIN          PHONE NO : 353 53 92371111

MOYNE UPPER, ENNISCORTHY          SE DECISION MADE: 01-DEC-10

COUNTY WEXFORD    EI              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SECRMARK BIOPSY SITE MARKING SYSTEM

HOLOGIC, INC.                     510(k) NO: K102768(SPECIAL)

ATTN: ALYSSA M  LOBO              PHONE NO : 877 887 2767   

6100 TECHNOLOGY CENTER DRIVE      SE DECISION MADE: 02-DEC-10

INDIANAPOLIS IN 46278             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES

BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K101577(SPECIAL)

ATTN: DIANA  HONG                 PHONE NO : 862 164 264467

SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 02-DEC-10

SHANGHAI    CH 20030              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: RENOVO (TM) SUTURE ANCHORS, RENOVO SS & PEEK PRODUCT CODES, MODELS 100-2001 THRU 100-520X, 400-0002 THRU 4007026X

CORE ESSENCE ORTHOPAEDICS, INC.   510(k) NO: K101126(TRADITIONAL)

ATTN: JEFF  MILLER                PHONE NO : 215 310 9534   

575A VIRGINIA DRIVE               SE DECISION MADE: 02-DEC-10

FT WASHINGTON PA 19034            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ADHESIVE ELECTRODES

RENO MEDICAL LIMITED              510(k) NO: K102842(TRADITIONAL)

ATTN: DIANA  HONG                 PHONE NO : 862 164 264467

P.O. BOX 237-023                  SE DECISION MADE: 02-DEC-10

SHANGHAI    CH 200237             510(k) STATEMENT



DEVICE: HYPERQ AD-100 SYSTEM

BIOLOGICAL SIGNAL PROCESSING LTD. 510(k) NO: K102579(SPECIAL)

ATTN: GEORGE J HATTUB             PHONE NO : 508 479 6116   

291 HILLSIDE AVENUE               SE DECISION MADE: 02-DEC-10

SOMERSET MA 02726                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LAMINOPLASY PLATING SYSTEM

AESCULAP IMPLANT SYSTEMS, INC.    510(k) NO: K103284(SPECIAL)

ATTN: LISA M BOYLE                PHONE NO : 610 984 9274   

3773 CORPORATE PWKY.              SE DECISION MADE: 02-DEC-10

CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)

BREATHE TECHNOLOGIES, INC.        510(k) NO: K102525(TRADITIONAL)

ATTN: CRAIG  COOMBS               PHONE NO : 510 337 0140   

1193 SHERMAN ST.                  SE DECISION MADE: 02-DEC-10

ALAMEDA CA 94501                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

VENTUS MEDICAL, INC.              510(k) NO: K102404(TRADITIONAL)

ATTN: MICHAEL  NEVARES            PHONE NO : 650 632 4189   

1301 SHOREWAY ROAD SUITE 425      SE DECISION MADE: 02-DEC-10

BELMONT CA 94002                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CONSENSUS TAPERSET HIP SYSTEM

CONSENSUS ORTHOPEDICS, INC        510(k) NO: K102399(TRADITIONAL)

ATTN: MATTHEW  HULL               PHONE NO : 916 355 7156   

1115 WINFIELD WAY SUITE 100       SE DECISION MADE: 02-DEC-10

EL DORADO HILLS CA 95762 9623     510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: EVOLVE EPS ORTHOLOC

WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K102352(SPECIAL)

ATTN: KELSEY  LEE                 PHONE NO : 901 290 5909   

5677 AIRLINE RD.                  SE DECISION MADE: 02-DEC-10

ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ELECTROCARDIOGRAPH

EDAN INSTRUMENTS, INC.            510(k) NO: K102830(SPECIAL)

ATTN: YUE  QIUHONG (TRACY)        PHONE NO : 86 755 26899197

3/F-B NANSHAN MEDICAL EQUIPMEN PARSE DECISION MADE: 02-DEC-10

SHENZHEN    CH 518067             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ENVIEW (TM)

CAREFUSION 2200                   510(k) NO: K102179(TRADITIONAL)

ATTN: PATRICIA A AYERS            PHONE NO : 858 246 0439   

6215 FERRIS SQUARE, SUITE #100    SE DECISION MADE: 02-DEC-10

SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS

GRIFFITHS AND NIELSEN LTD         510(k) NO: K101224(TRADITIONAL)

ATTN: EDWIN  LINDSAY              PHONE NO : 447 917 134922

STANE STREET, SLINFORD            SE DECISION MADE: 03-DEC-10

HORSHAM, WEST SUSSEX    UK RH13 0T510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BIOHARNESS

ZEPHYR TECHNOLOGY CORPORATION     510(k) NO: K100040(TRADITIONAL)

ATTN: CODE  CUBITT                PHONE NO : 443 569 3603   

1 ANNAPOLIS STREET, SUITE 200     SE DECISION MADE: 03-DEC-10

ANNAPOLIS MD 21401                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PACENTRIC CONNECT, TRAVELER AND WEB

FIMREITE SOFTWARE AS              510(k) NO: K100837(ABBREVIATED)

ATTN: SVEIN  FIMREITE             PHONE NO : 47 99 744114

TORGGATA 26                       SE DECISION MADE: 03-DEC-10

HORTEN    NO 3181                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ANYPLUS PEEK CAGES

GS MEDICAL CO., LTD.              510(k) NO: K100516(TRADITIONAL)

ATTN: DONALD W GUTHNER            PHONE NO : 603 369 3550   

111 HILL ROAD PO BOX 395          SE DECISION MADE: 03-DEC-10

DOUGLASSVILLE PA 19818            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BOSWORTH AIR POLISHER

HARRY J. BOSWORTH CO.             510(k) NO: K100731(TRADITIONAL)

ATTN: GARY  CHUVEN                PHONE NO : 847 679 3400   

7227 NORTH HAMLIN AVE.            SE DECISION MADE: 03-DEC-10

SKOKIE IL 60076                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BONART MODEL ART-IM1 IMPLANTOR SYSTEM & ACCESSORIES

BONART CO. LTD.                   510(k) NO: K100785(TRADITIONAL)

ATTN: ERIC L ONG                  PHONE NO : 909 594 8066   

398 S. LEMON CREEK DR. SUITE G    SE DECISION MADE: 03-DEC-10

WALNUT CA 91789                   510(k) STATEMENT



DEVICE: BIOPRO POLAR HEAD

BIOPRO, INC.                      510(k) NO: K100761(TRADITIONAL)

ATTN: DAVID  MRAK                 PHONE NO : 810 982 7777   

17 SEVENTEENTH ST.                SE DECISION MADE: 03-DEC-10

PORT HURON MI 48060               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: STELLATE GRIDVIEW

EXCEL-TECH LTD. (XLTEK)           510(k) NO: K100126(ABBREVIATED)

ATTN: GOLDY  SINGH                PHONE NO : 905 829 5300

2568 BRISTOL CIR.                 SE DECISION MADE: 03-DEC-10

OAKVILLE, ONTARIO    CA L6H 5S1   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE

SENTEC AG                         510(k) NO: K101690(TRADITIONAL)

ATTN: STEPHEN H GORSKI            PHONE NO : 262 594 2114   

S65 W35739 PIPER ROAD             SE DECISION MADE: 03-DEC-10

EAGLE WI 53119                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PREMIO 10 MOXA

SEDATELEC                         510(k) NO: K101267(TRADITIONAL)

ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   

5401 S. COTTONWOOD COURT          SE DECISION MADE: 03-DEC-10

GREENWOOD VILLAGE CO 80121        510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

BIO-RAD LABORATORIES              510(k) NO: K092587(TRADITIONAL)

ATTN: PATRICIA  KLIMLEY           PHONE NO : 510 741 6263   

5500 E. SECOND ST                 SE DECISION MADE: 03-DEC-10

BENICIA CA 94510                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER

ZIMMER, INC.                      510(k) NO: K101229(TRADITIONAL)

ATTN: REBECCA  BROOKS             PHONE NO : 574 371 8033   

P.O. BOX 708                      SE DECISION MADE: 03-DEC-10

WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PHYSIOFLOW ENDURO

VASOCOM, INC.                     510(k) NO: K103283(SPECIAL)

ATTN: JAMES  GUNNERSON            PHONE NO : 215 826 9998   

2014 FORD RD., UNIT G             SE DECISION MADE: 03-DEC-10

BRISTOL PA 19007                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ENCODE PATIENT SPECIFIC ABUTMENT

BIOMET 3I, INC.                   510(k) NO: K102209(TRADITIONAL)

ATTN: SIMEON  SIMONE              PHONE NO : 561 776 6831   

4555 RIVERSIDE DR.                SE DECISION MADE: 03-DEC-10

PALM BEACH GARDENS FL 33410       510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: RELIANCE ENDOSCOPE PROCESSING SYSTEM

STERIS CORPORATION                510(k) NO: K102244(TRADITIONAL)

ATTN: ROBERT F SULLIVAN           PHONE NO : 440 392 7695   

5960 HEISLEY ROAD                 SE DECISION MADE: 03-DEC-10

MENTOR OH 44060                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS

ZIMMER, INC.                      510(k) NO: K101730(TRADITIONAL)

ATTN: BRADLEY  STRASSER           PHONE NO : 574 372 4780   

P.O. BOX 708                      SE DECISION MADE: 03-DEC-10

WARSAW IN 46581 0708              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: KLASSIC HD HIP SYSTEM

TOTAL JOINT ORTHOPEDICS, INC.     510(k) NO: K100445(TRADITIONAL)

ATTN: KIT  CARIQUITAN             PHONE NO : 408 400 0856   

155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 03-DEC-10

SUNNYVALE CA 94089                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PLEURAFLOW CATHETER SYSTEM

CLEAR CATHETER SYSTEMS            510(k) NO: K093565(TRADITIONAL)

ATTN: MONICA  DOUGHERTY           PHONE NO : 210 957 2083   

901 KING ST., SUITE 200           SE DECISION MADE: 03-DEC-10

ALEXANDRIA VA 22314               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DMP PIT & FISSURE SEALANT

DMP LTD                           510(k) NO: K102252(TRADITIONAL)

ATTN: DIMITRIS  PRANTSIDIS        PHONE NO : 003 022 99023041

KALYVION AVENUE MARKOPOULO INDUSTRSE DECISION MADE: 03-DEC-10

MARKOPOULO, ATTIKI    GR 19003    510(k) STATEMENT



DEVICE: VERTEX RAPID SIMPLIFIED

VERTEX-DENTAL B.V.                510(k) NO: K102654(TRADITIONAL)

ATTN: WILLIAM  GREENROSE          PHONE NO : 603 369 3550   

22 RIVER ROAD                     SE DECISION MADE: 03-DEC-10

CLAREMONT NH 03743                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT

CENDRES & METAUX SA               510(k) NO: K102382(SPECIAL)

ATTN: TANJA  BONGNI               PHONE NO : 415 836 02000

RUE DE BOUJEAN 122                SE DECISION MADE: 03-DEC-10

BIEL/BIENNE    SZ 2501            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PATRIOT TRANSCONTINENTAL M SPACERS

GLOBUS MEDICAL, INC.              510(k) NO: K102313(TRADITIONAL)

ATTN: KELLY J BAKER               PHONE NO : 610 930 1800   

2560 GENERAL ARMISTEAD AVE. VALLEYSE DECISION MADE: 03-DEC-10

AUDUBON PA 19403                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P

HASS CORP.                        510(k) NO: K102305(TRADITIONAL)

ATTN: PRISCILLA  CHUNG            PHONE NO : 714 844 2612   

2341 W. CRESCENT AVE. #3          SE DECISION MADE: 03-DEC-10

ANAHEIM CA 92801                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MERETE LOCKING BONE PLATE SYSTEM II

MERETE MEDICAL GMBH               510(k) NO: K102688(TRADITIONAL)

ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 914 967 1532   

49 PURCHASE STREET                SE DECISION MADE: 03-DEC-10

RYE NY 10580                      510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: IROOT FS

INNOVATIVE BIOCERAMIX INC.        510(k) NO: K102867(SPECIAL)

ATTN: QUANZU  YANG                PHONE NO : 604 221 6800

1628 WEST 75TH AVE.               SE DECISION MADE: 03-DEC-10

VANCOUVER, BC    CA V6P 6G2       510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

MEDTRONIC INC.                    510(k) NO: K103314(SPECIAL)

ATTN: JEFFREY L KOLL              PHONE NO : 763 514 9842   

8200 CORAL SEA STREET NE MS MV S11SE DECISION MADE: 03-DEC-10

MOUNDS VIEW MN 55112              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PC ECG

EDAN INSTRUMENTS, INC.            510(k) NO: K102854(SPECIAL)

ATTN: YUE  QIUHONG (TRACY)        PHONE NO : 867 552 6899197

NANHAI ROAD 1019# NANSHEN         SE DECISION MADE: 03-DEC-10

SHENZHEN, GUANGDONG    CH 518067  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: GAMMA-BSM; BETA-BSM; EQUIVABONE

ETEX CORPORATION                  510(k) NO: K102812(SPECIAL)

ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 617 817 6342   

38 SIDNEY STREET                  SE DECISION MADE: 03-DEC-10

CAMBRIDGE MA 02139                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS

BIOMEDICAL DIAGNOSTICS (BMD) SA   510(k) NO: K102607(TRADITIONAL)

ATTN: COURIVAUD  CHRISTELLE       PHONE NO : 331 646 21012

ACTIPOLE 25 4-6 BLD DE BEAUBOURG  SE DECISION MADE: 03-DEC-10

MARNE LA VALLEE CEDEX 2    FR 7743510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079

POREX SURGICAL, INC.              510(k) NO: K101835(TRADITIONAL)

ATTN: STEPHANIE  FULLARD          PHONE NO : 678 479 1758   

15 DART RD.                       SE DECISION MADE: 03-DEC-10

NEWNAN GA 30265                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PRODESSE PROADENO

GEN-PROBE PRODESSE, INC           510(k) NO: K102952(TRADITIONAL)

ATTN: EMILY  ZIELGER              PHONE NO : 262 953 8421   

W229 N1870 WESTWOOD DR            SE DECISION MADE: 03-DEC-10

WAUKESHA WI 53186                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE

HEMOSTASIS, LLC                   510(k) NO: K102459(TRADITIONAL)

ATTN: BERNARD  HORWATH            PHONE NO : 651 855 1466   

5000 TOWNSHIP PARKWAY             SE DECISION MADE: 03-DEC-10

ST. PAUL MN 55110                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CRYOPETTE

MID-ATLANTIC DIAGNOSTICS, INC.    510(k) NO: K100596(TRADITIONAL)

ATTN: ELISA D HARVEY              PHONE NO : 301 774 0511   

18905 CELEBRITY LANE              SE DECISION MADE: 06-DEC-10

SANDY SPRING MD 20860             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: GC AADVA IMPLANT SYSTEM

GC AMERICA, INC.                  510(k) NO: K093749(ABBREVIATED)

ATTN: CARL  JENKINS               PHONE NO : 874 234 7500   

10 E. SCRANTON AVENUE SUITE 201   SE DECISION MADE: 06-DEC-10

LAKE BLUFF IL 60044               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MEDICON MOGEN CLAMP

MEDICON, E.G.                     510(k) NO: K100916(TRADITIONAL)

ATTN: JOACHIM  SCHMID             PHONE NO : 497 462 2009

GANSACKER 15                      SE DECISION MADE: 06-DEC-10

TUTTLINGEN    GM D-78532          510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM

HARVEST TECHNOLOGIES, CORP.       510(k) NO: K103340(SPECIAL)

ATTN: JOHN D BONASERA             PHONE NO : 508 732 7500   

40 GRISSOM RD, SUITE 100          SE DECISION MADE: 06-DEC-10

PLYMOUTH MA 02360                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: EVERCROSS 0.035 OTW PTA DILATION CATHETER

EV3 INC                           510(k) NO: K103322(TRADITIONAL)

ATTN: DAVID  WORRELL, MS, RAC     PHONE NO : 763 398 7344   

3033 CAMPUS DRIVE                 SE DECISION MADE: 06-DEC-10

PLYMOUTH MN 55441                 510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH

ROCHE DIAGNOSTICS                 510(k) NO: K103099(TRADITIONAL)

ATTN: SUSAN  HOLLANDBECK          PHONE NO : 317 521 3380   

9115 HAGUE ROAD PO BOX 50416      SE DECISION MADE: 06-DEC-10

INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5

EDWARDS LIFESCIENCES, LLC.        510(k) NO: K100739(TRADITIONAL)

ATTN: PATRICIA  MILBANK           PHONE NO : 949 250 2603   

ONE EDWARDS WAY                   SE DECISION MADE: 07-DEC-10

IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M

EDWARDS LIFESCIENCES, LLC.        510(k) NO: K100709(TRADITIONAL)

ATTN: PATRICIA  MILBANK, JD       PHONE NO : 949 250 2603   

ONE EDWARDS WAY                   SE DECISION MADE: 07-DEC-10

IRVINE CA 92614                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: S 100 PEDICLE SCREW SYSTEM

RENOVIS SURGICAL TECHNOLOGIES, LLC510(k) NO: K101682(TRADITIONAL)

ATTN: J.D.  WEBB                  PHONE NO : 512 388 0199   

1001 OAKWOOD BLVD                 SE DECISION MADE: 07-DEC-10

ROUND ROCK TX 78681               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SKELETAL DYNAMICS STERILIZATION TRAYS

SKELETAL DYNAMICS, LLC            510(k) NO: K102103(TRADITIONAL)

ATTN: ANA M ESCAGEDO              PHONE NO : 305 596 7585   

8905 SW 87 AVENUE, SUITE 201      SE DECISION MADE: 07-DEC-10

MIAMI FL 33176                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: AIDERA DIASEND SYSTEM

AIDERA AB                         510(k) NO: K101806(TRADITIONAL)

ATTN: ANDERS  SONESSON            PHONE NO : 46 31 7411785

MEDICINAREGATAN 8A                SE DECISION MADE: 07-DEC-10

GOTEBORG    SW SE 413 46          510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ARMANDA 14 PTA CATHETER

ABBOTT VASCULAR INC.              510(k) NO: K102705(TRADITIONAL)

ATTN: LAARNI  RICAFORT            PHONE NO : 408 845 0688   

3200 LAKESIDE DRIVE               SE DECISION MADE: 07-DEC-10

SANTA CLARA CA 95054              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MEDICAL MAGNETIC TAPE RECORDER

WPR MEDICAL AS                    510(k) NO: K102111(TRADITIONAL)

ATTN: CONSTANCE G BUNDY           PHONE NO : 763 574 1976   

435 RICE CREEK TERRACE            SE DECISION MADE: 07-DEC-10

FRIDLEY MN 55432                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NEUMOVENT GRAPHNET MODEL 3179L1V

TECME S.A.                        510(k) NO: K101401(TRADITIONAL)

ATTN: RAYMOND  KELLY              PHONE NO : 603 595 0095   

56B SHADOWBROOK DRIVE             SE DECISION MADE: 07-DEC-10

HUDSON NH 03051                   510(k) STATEMENT



DEVICE: VIPER SYSTEM, EXPEDIUM SYSTEM

DEPUY SPINE, INC.                 510(k) NO: K101993(SPECIAL)

ATTN: FRANK  JURCZAK              PHONE NO : 508 828 3288   

325 PARAMOUNT DR.                 SE DECISION MADE: 07-DEC-10

RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PRONEX

DIREX SYSTEMS CORP.               510(k) NO: K102765(TRADITIONAL)

ATTN: LARISA  GERSHTEIN           PHONE NO : 888 874 7837   

437 TURNPIKE ST.                  SE DECISION MADE: 07-DEC-10

CANTON MA 02021                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ARCOS INTERLOCKING DISTAL STEMS

BIOMET MANUFACTURING CORP.        510(k) NO: K100469(TRADITIONAL)

ATTN: BECKY  EARL                 PHONE NO : 574 267 6639   

56 EAST BELL DRIVE P.O. BOX 587   SE DECISION MADE: 07-DEC-10

WARSAW IN 46581 0587              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SPACELABS MEDICAL PATIENT MONITORS

SPACELABS MEDICAL INC.            510(k) NO: K102422(SPECIAL)

ATTN: DAVID J GERAGHTY            PHONE NO : 425 657 7200   

5150 220TH AVE SE                 SE DECISION MADE: 07-DEC-10

ISSAQUAH WA 98029                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES

HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K102282(TRADITIONAL)

ATTN: STEPHANIE  FITTS            PHONE NO : 201 831 5405   

325 CORPORATE DRIVE               SE DECISION MADE: 07-DEC-10

MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NIHON KOHDEN CNS-6200 SERIES CENTRAL NURSE STATION, MODEL CNS-6201

NIHON KOHDEN CORP.                510(k) NO: K102376(SPECIAL)

ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   

90 ICON STREET                    SE DECISION MADE: 07-DEC-10

FOOTHILL RANCH CA 92610           510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM

SUSPENSION ORTHOPAEDIC SOLUTIONS, 510(k) NO: K102095(TRADITIONAL)

ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   

80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 07-DEC-10

SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NEMA-ST, MODEL V1.0.2

NERVOMATRIX LTD                   510(k) NO: K100668(TRADITIONAL)

ATTN: DAN  LAOR                   PHONE NO : 972 482 46632

SIRENI 6                          SE DECISION MADE: 08-DEC-10

HAIFA    IS 32972                 510(k) STATEMENT



DEVICE: TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYSTEM

TANGO3, LLC                       510(k) NO: K093641(TRADITIONAL)

ATTN: LORI  HOLDER                PHONE NO : 817 368 6179   

141A CITIZENS BLVD                SE DECISION MADE: 08-DEC-10

SIMPSONVILLE KY 40067             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD

MAQUET CARDIOPULMONARY AG         510(k) NO: K101153(TRADITIONAL)

ATTN: KATRIN  SCHWENKGLENKS       PHONE NO : 497 478 9210

HECHINGER STRASSE 38              SE DECISION MADE: 08-DEC-10

HIRRLINGEN    GM 72145            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: OPTIGEN TOTAL KNEE SYSTEM

U&I CORP.                         510(k) NO: K102367(TRADITIONAL)

ATTN: GYEONG-JE  KWON             PHONE NO : 823 185 20102

529-1 YONGHYUN-DONG               SE DECISION MADE: 08-DEC-10

EUIJUNGBU, KYUNGGI-DO    KS 480-05510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER

MANUKA MEDICAL LIMITED            510(k) NO: K102659(TRADITIONAL)

ATTN: JAMES  SMITH                PHONE NO : 949 340 7261   

29442 POINTE ROYALE               SE DECISION MADE: 08-DEC-10

LAGUNA NIGUEL CA 92677            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SEEKER CROSSING SUPPORT CATHETER

BARD PERIPHERAL VASCULAR, INC.    510(k) NO: K103367(TRADITIONAL)

ATTN: CANDACE  WADE               PHONE NO : 480 303 2662   

1625 WEST 3RD ST.                 SE DECISION MADE: 08-DEC-10

TEMPE AZ 85280                    510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: PRUITT CAROTID KIT

LEMAITRE VASCULAR, INC.           510(k) NO: K103356(SPECIAL)

ATTN: VIC  ZHANG                  PHONE NO : 781 221 2266   

63 2ND AVENUE                     SE DECISION MADE: 08-DEC-10

BURLINGTON MA 01803               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS

3M COMPANY                        510(k) NO: K101910(TRADITIONAL)

ATTN: SUZANNE  LEUNG              PHONE NO : 651 575 8052   

3M CENTER, BLDG. 275-5W-06        SE DECISION MADE: 08-DEC-10

ST. PAUL MN 55133 3275            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SUSPENSION ACROMIOCLAVICULAR (AC) REPAIR SYSTEM

SUSPENSION ORTHOPAEDIC SOLUTIONS, 510(k) NO: K102143(TRADITIONAL)

ATTN: JOSEPH  AZARY               PHONE NO : 203 922 0105   

80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 08-DEC-10

SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: AURA

SDI LIMITED                       510(k) NO: K102984(TRADITIONAL)

ATTN: RUTH  EZEKIEL               PHONE NO : 613 872 77111

3-13 BRUNSDON STREET              SE DECISION MADE: 08-DEC-10

BAYSWATER, VICTORIA    AS 3153    510(k) STATEMENT



DEVICE: HYDROCOLOR 5

CASCADES DEVICE CONSULTING ASSOCIA510(k) NO: K102739(TRADITIONAL)

ATTN: GERALD W SHIPPS             PHONE NO : 541 389 5935   

19379 BLUE LAKE LOOP              SE DECISION MADE: 08-DEC-10

BEND OR 97702 1923                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TRAUMA GAUZE AG, OMNI-STAT HEMOSTATIC ANTI

MEDTRADE PRODUCTS LTD.            510(k) NO: K102965(TRADITIONAL)

ATTN: JONATHAN D RANFIELD         PHONE NO : 440 127 0500019

ELECTRA HOUSE CREWE BUSINESS PARK SE DECISION MADE: 08-DEC-10

CHESHIRE    UK CW1 6GL            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: IMMULISA DSDNA ANTIBODY ELISA

IMMCO DIAGNOSTICS, INC.           510(k) NO: K101319(TRADITIONAL)

ATTN: KEVIN  LAWSON               PHONE NO : 716 691 0091   

60 PINEVIEW DR.                   SE DECISION MADE: 09-DEC-10

BUFFALO NY 14228 2120             510(k) STATEMENT

                                  THIRD PARTY REVIEW



DEVICE: HIP SEXTANT INSTRUMENT SYSTEM

SURGICAL PLANNING ASSOCIATES      510(k) NO: K093491(TRADITIONAL)

ATTN: JOSEPH  AZARY               PHONE NO : 203 922 0105   

80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 09-DEC-10

MEDFORD MA 02155                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SELF RETAINING SOFT TISSUE RETRACTOR

KOROS USA, INC.                   510(k) NO: K101609(TRADITIONAL)

ATTN: TIBOR  KOROS                PHONE NO : 805 529 0825   

610 FLINN AVE.                    SE DECISION MADE: 09-DEC-10

MOORPARK CA 93021                 510(k) STATEMENT



DEVICE: 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES

SYNTHES (USA)                     510(k) NO: K102694(TRADITIONAL)

ATTN: CHRISTOPHER  HACK, ESQ      PHONE NO : 610 719 6940   

1301 GOSHEN PKWY.                 SE DECISION MADE: 09-DEC-10

WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS

MEMTEC CORP.                      510(k) NO: K102723(TRADITIONAL)

ATTN: DENNIS  GARBOSKI            PHONE NO : 603 893 8080   

68 STILES RD. UNIT D              SE DECISION MADE: 09-DEC-10

SALEM NH 03079                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NOBEL ACTIVE 3.0

NOBEL BIOCARE AB                  510(k) NO: K102436(TRADITIONAL)

ATTN: HERBERT  CRANE              PHONE NO : 714 282 5074

15 BOHUSGATAN, P.O. BOX 5190      SE DECISION MADE: 09-DEC-10

GOTEBORG    SW S-402 26           510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399

PREMIUM PLUS INTERNATIONAL LIMITED510(k) NO: K100854(TRADITIONAL)

ATTN: DENNIS  NG                  PHONE NO : 852 276 13211

33 WANG YIP STREET WEST YUEN LONG SE DECISION MADE: 09-DEC-10

HONG KONG    CH                   510(k) STATEMENT



DEVICE: KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR

ANDON MEDICAL CO., LTD.           510(k) NO: K102609(ABBREVIATED)

ATTN: LIU  YI                     PHONE NO : 86 22 60526161

# 3 JIN PING STREET, YA AN RD NANKSE DECISION MADE: 09-DEC-10

TIANJIN    CH 300190              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEM

SORIN GROUP DEUTSCHLAND GMBH      510(k) NO: K101046(TRADITIONAL)

ATTN: ROSINA  ROBINSON            PHONE NO : 508 643 0434   

49 PLAIN STREET                   SE DECISION MADE: 09-DEC-10

NORTH ATTLEBORO MA 02760          510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MULLINS-X PTV CATHETER

NUMED, INC.                       510(k) NO: K102473(TRADITIONAL)

ATTN: NICHELLE  LAFLESH           PHONE NO : 315 328 4491   

2880 MAIN ST.                     SE DECISION MADE: 09-DEC-10

HOPKINTON NY 12965                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: OPUS DIAGNOSTIC ULTRASOUND SYSTEM & TRANSDUCERS

CHANG GUNG MEDICAL TECHNOLOGY CO.,510(k) NO: K102989(TRADITIONAL)

ATTN: BOB  LEIKER                 PHONE NO : 925 556 1302   

7263 CRONIN CIRCLE                SE DECISION MADE: 09-DEC-10

DUBLIN CA 94568                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PREVISION HIP SYSTEM WITH RECON RING

AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K102424(TRADITIONAL)

ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   

3773 CORPORATE PARKWAY            SE DECISION MADE: 09-DEC-10

CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000

KEELER INSTRUMENTS, INC.          510(k) NO: K093298(TRADITIONAL)

ATTN: EUGENE  VAN ARSDALE         PHONE NO : 610 353 4350   

456 PKWY.                         SE DECISION MADE: 10-DEC-10

BROOMALL PA 19008                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD

TEI BIOSCIENCES INC.              510(k) NO: K100261(ABBREVIATED)

ATTN: KENNETH  JAMES              PHONE NO : 617 268 1616   

7 ELKINS ST.                      SE DECISION MADE: 10-DEC-10

BOSTON MA 02127                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ABL837 FLEX ANALYZER

RADIOMETER MEDICAL APS            510(k) NO: K100777(ABBREVIATED)

ATTN: ROWENA  JANSSON             PHONE NO : 45 381 73852

AKANDEVEJ 21                      SE DECISION MADE: 10-DEC-10

BRONSHOJ    DA DK-2700            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: RAPIDVIT BLAST, RAPIDWARM BLAST

VITROLIFE SWEDEN AB               510(k) NO: K101003(TRADITIONAL)

ATTN: KJELL  KJORK                PHONE NO : 463 172 18077

BOX 9080                          SE DECISION MADE: 10-DEC-10

SE-400 92 GOTEBORG    SW          510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH

ETHICON ENDO-SURGERY, INC.        510(k) NO: K101520(TRADITIONAL)

ATTN: RUTH  WOOD                  PHONE NO : 513 337 3566   

4545 CREEK ROAD ML#132            SE DECISION MADE: 10-DEC-10

CINCINATTI OH 45242               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PIXI PEDIATRIC MASK

RESMED LTD.                       510(k) NO: K102224(TRADITIONAL)

ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   

9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 10-DEC-10

SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DEPUY ATTUNE KNEE SYSTEM

DEPUY ORTHOPAEDICS, INC.          510(k) NO: K101433(TRADITIONAL)

ATTN: KATHY  BOGGS                PHONE NO : 574 371 4945   

700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 10-DEC-10

WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: GENESYS SPINE INTERBODY FUSION SYSTEM

GENESYS SPINE                     510(k) NO: K103034(TRADITIONAL)

ATTN: JOSH  KAUFMANN              PHONE NO : 512 560 3446   

1250 CAPITAL OF TEXAS HWY SO. BUILSE DECISION MADE: 10-DEC-10

AUSTIN TX 78746                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: VASCUCOMP

THERMOTEK, INC.                   510(k) NO: K103247(TRADITIONAL)

ATTN: NIRAN  BALACHANDRAN         PHONE NO : 972 874 4900   

1200 LAKESIDE PARKWAY #200        SE DECISION MADE: 10-DEC-10

FLOWER MOUND TX 75028             510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: INFUSION SETS

HOSPIRA, INC.                     510(k) NO: K103344(SPECIAL)

ATTN: REBECCA  ANDERSEN           PHONE NO : 224 212 5316   

275 NORTH FIELD DR.               SE DECISION MADE: 10-DEC-10

LAKE FOREST IL 60045              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: RII INFRARED EAR THERMOMETER,

RADIANT INNOVATION, INC.          510(k) NO: K102187(SPECIAL)

ATTN: JAMES  HUANG                PHONE NO : 886 361 11666

1F,NO. 3,INDUSTRIAL E. 9TH RD SCIESE DECISION MADE: 10-DEC-10

HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS

KIMBERLY CLARK CORPORATION        510(k) NO: K103311(SPECIAL)

ATTN: CHERYL  SANZARE             PHONE NO : 770 587 7131   

2100 WINCHESTER ROAD              SE DECISION MADE: 10-DEC-10

NEENAH WI 54956                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: INZONE DETACHMENT SYSTEM

BOSTON SCIENTIFIC CORP.           510(k) NO: K103008(SPECIAL)

ATTN: JAMES  LEATHLEY             PHONE NO : 510 440 7836   

47900 BAYSIDE PARKWAY             SE DECISION MADE: 10-DEC-10

FREMONT CA 94538 6515             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM

HAEMONETICS CORP.                 510(k) NO: K101907(TRADITIONAL)

ATTN: GREG  CALDER                PHONE NO : 781 356 9538   

400 WOOD RD. P.O. BOX 9114        SE DECISION MADE: 10-DEC-10

BRAINTREE MA 02184                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: APEX SPINE SYSTEM W/ COCR RODS

SPINECRAFT LLC                    510(k) NO: K102488(SPECIAL)

ATTN: AMI  AKALLAL-ASAAD          PHONE NO : 708 531 9700   

2215 ENTERPRISE DRIVE SUITE 1504  SE DECISION MADE: 10-DEC-10

WESTCHESTER IL 60154              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: APTUS 1.5 TRILOCK

MEDARTIS AG                       510(k) NO: K102537(SPECIAL)

ATTN: KEVIN A THOMAS              PHONE NO : 858 792 1235   

11234 EL CAMINO REAL, SUITE 200   SE DECISION MADE: 10-DEC-10

SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,

LIMA-LTO S.P.A.                   510(k) NO: K100858(TRADITIONAL)

ATTN: CHERYL  HASTINGS            PHONE NO : 574 527 4220   

PO BOX 696                        SE DECISION MADE: 10-DEC-10

WINONA LAKE IN 46590              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: WILLOW/ELM PTA BALLOON DILATATION CATHETER

CREAGH MEDICAL LTD                510(k) NO: K102645(TRADITIONAL)

ATTN: MAUREEN  O'CONNELL          PHONE NO : 978 207 1245   

5 TIMBER LANE                     SE DECISION MADE: 10-DEC-10

NORTH READING MA 01864            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS  / 15MM ID CONNECTIONS

THAYER MEDICAL CORP.              510(k) NO: K102658(SPECIAL)

ATTN: JAMES M STRICKLAND          PHONE NO : 520 790 5393   

4575 SOUTH PALO VERDE RD., SUITE 3SE DECISION MADE: 10-DEC-10

TUCSON AZ 85714 1961              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ELECTRO INTERSTITIAL SCAN

L.D. TECHNOLOGY, LLC              510(k) NO: K102166(TRADITIONAL)

ATTN: RICHARD  CLEMENT            PHONE NO : 305 594 2145   

11459 NW 34 STREET                SE DECISION MADE: 10-DEC-10

MIAMI FL 33178                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED

DRAEGER MEDICAL AG & CO. KG       510(k) NO: K102618(TRADITIONAL)

ATTN: JOYCE  KILROY               PHONE NO : 215 660 2626   

3135 QUARRY ROAD                  SE DECISION MADE: 10-DEC-10

TELFORD PA 18969                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: QUANTA CYBER TM 150W

QUANTA SYSTEM SPA                 510(k) NO: K102749(TRADITIONAL)

ATTN: ISABELLA  CARRER            PHONE NO : 390 331 376797

VIA IV NOVEMBRE, 116              SE DECISION MADE: 10-DEC-10

SOLBIATE OLONA, VA    IT 21058    510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: FRONTIER DEVICES NEURO SYSTEM

FOLSOM METAL PRODUCTS, INC.       510(k) NO: K100205(TRADITIONAL)

ATTN: DON  PETERSON               PHONE NO : 205 733 0901   

153 CAHABA VALLEY PKWY.           SE DECISION MADE: 13-DEC-10

PELHAM AL 35124                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SUSTAIN SPACE MAINTENANCE SYSTEM

MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K100779(TRADITIONAL)

ATTN: MICHELLE  OBENAUER          PHONE NO : 901 399 2117   

1800 PYRAMID PLACE                SE DECISION MADE: 13-DEC-10

MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MED-RX PEDIATRIC FEEDING TUBES AND ACCESSORIES

BENLAN, INC.                      510(k) NO: K100700(TRADITIONAL)

ATTN: CHERYL  BROWN               PHONE NO : 905 829 5004

2760 BRIGHTON RD.                 SE DECISION MADE: 13-DEC-10

OAKVILLE, ONTARIO    CA L6H 5T4   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: STRAUMANN CARES BRIDGE; STRAUMANN CARES DOLDER BAR

INSTITUT STRAUMANN AG             510(k) NO: K101465(TRADITIONAL)

ATTN: JANET  KAY                  PHONE NO : 978 747 2575   

60 MINUTEMAN ROAD                 SE DECISION MADE: 13-DEC-10

ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: TREVAIR CHAIR ADULT

PATMONT MOTOR WERKS, INC.         510(k) NO: K102061(TRADITIONAL)

ATTN: STEVEN J PATMONT            PHONE NO : 775 782 0113   

2220 MERIDIAN BLVD                SE DECISION MADE: 13-DEC-10

MINDEN NV 89423                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DIGITAL THERMOMETER; DIGITAL THERMOMETER

INTERNATIONAL REGULATORY CONSULTAN510(k) NO: K102718(TRADITIONAL)

ATTN: JACOB  CHANG                PHONE NO : 886 4 22465396

16F-2(16A), SEC. 2 CHONG DE RD    SE DECISION MADE: 13-DEC-10

TAICHUNG    CH 406                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BIORAPTOR CURVED 2.3 PK SUTURE ANCHORS

SMITH & NEPHEW ENDOSCOPY, INC.    510(k) NO: K102660(TRADITIONAL)

ATTN: KATHLEEN  SOLOMON           PHONE NO : 978 749 1605   

150 MINUTEMAN ROAD                SE DECISION MADE: 13-DEC-10

ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM

EXACTECH, INC.                    510(k) NO: K103419(SPECIAL)

ATTN: PATRICK  HUGHES             PHONE NO : 352 377 1140   

2320 N.W. 66TH COURT              SE DECISION MADE: 13-DEC-10

GAINESVILLE FL 32653              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: VASCUTRAK PTA DILATATION CATHETER

C. R. BARD, INC.                  510(k) NO: K103459(TRADITIONAL)

ATTN: CANDACE  WADE               PHONE NO : 480 303 2662   

1625 W 3RD STREET                 SE DECISION MADE: 13-DEC-10

TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: TRABECULAR METAL TIBIAL CONE AUGMENTS

ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K102896(TRADITIONAL)

ATTN: KATHLEEN  RUTHERFORD        PHONE NO : 973 576 0139   

10 POMEROY RD.                    SE DECISION MADE: 13-DEC-10

PARSIPPANY NJ 07054               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: POWDERED VINYL PATIENT EXAMINIATION GLOVES, CLEAR (NON-COLORED)

HEZE JUXINYUAN FOOD CO., LTD      510(k) NO: K102976(TRADITIONAL)

ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441

RM 1606 BLD 1 JIAN XIANG YUAN N209SE DECISION MADE: 13-DEC-10

BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: VITAL SUTURES, SUTUREX, CIRUGIA PERUANA

UNILENE S.A.C.                    510(k) NO: K100780(TRADITIONAL)

ATTN: KEVIN  WALLS, RAC           PHONE NO : 720 962 5412   

5401 S. COTTONWOOD CT.            SE DECISION MADE: 14-DEC-10

GREENWOOD VILLAGE CO 80121        510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SAFECT MODEL VER 1.0

MEDIC VISION BRAIN TECHNOLOGIES LT510(k) NO: K100372(TRADITIONAL)

ATTN: DAN  LAOR                   PHONE NO : 972 482 46632

6 SIRENI                          SE DECISION MADE: 14-DEC-10

HAIFA    IS 32972                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: INBONE TOTAL ANKLE SYSTEM MODEL 200347902

WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K103374(SPECIAL)

ATTN: KELSEY  LEE                 PHONE NO : 901 290 5909   

5677 AIRLINE RD.                  SE DECISION MADE: 14-DEC-10

ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: COMFORT STANDING WHEELCHAIR, HERO SERIES

COMFORT ORTHOPEDIC CO. LTD.       510(k) NO: K102734(TRADITIONAL)

ATTN: JEN  KE-MIN                 PHONE NO : 

2064 TAMARIN DRIVE                SE DECISION MADE: 14-DEC-10

COLUMBUS OH 43235                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SIMMETRY SACROILIAC JOINT FUSION SYSTEM

ZYGA TECHNOLOGY, INC.             510(k) NO: K102907(TRADITIONAL)

ATTN: DIANE  BRINZA               PHONE NO : 612 455 1061   

700 10TH AVENUE SOUTH, SUITE 400  SE DECISION MADE: 14-DEC-10

MINNEAPOLIS MN 55415              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SPECIALTY ASSAYED CONTROL-2

HELENA LABORATORIES               510(k) NO: K100103(TRADITIONAL)

ATTN: PATRICIA  FRANKS            PHONE NO : 409 842 3714   

1530 LINDBERGH DR. P.O. BOX 752   SE DECISION MADE: 15-DEC-10

BEAUMONT TX 77704                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ACTIVON TULLE

CALIDAD SOLUTIONS, INC.           510(k) NO: K101118(TRADITIONAL)

ATTN: JOHN  BILLINGS              PHONE NO : 206 575 7762   

22433 72 AVENUE S                 SE DECISION MADE: 15-DEC-10

KENT WA 98032                     510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: IMMUNOCAP ALLERGEN F20,  ALMOND MODEL: 14-4179-01

PHADIA AB                         510(k) NO: K100999(TRADITIONAL)

ATTN: MARTIN  MANN                PHONE NO : 269 492 1957   

4169 COMMERCIAL AVENUE            SE DECISION MADE: 15-DEC-10

PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201

TAIDOC TECHNOLOGY CORPORATION     510(k) NO: K101012(TRADITIONAL)

ATTN: TELING  HSU                 PHONE NO : 886 266 258188

3F, 5F, NO 127 WUGONG 2ND RD WUGU SE DECISION MADE: 15-DEC-10

TAIPEI COUNTY    TW 248           510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS  ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2

SEPPIM S.A.S.                     510(k) NO: K100525(TRADITIONAL)

ATTN: DEBRA  HUTSON               PHONE NO : 425 482 5174   

21720 23RD DR SE SUITE 150        SE DECISION MADE: 15-DEC-10

BOTHELL WA 98021                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT

ANGIODYNAMICS, INC.               510(k) NO: K102796(TRADITIONAL)

ATTN: TERI  JUCKETT               PHONE NO : 518 795 1142   

603 QUEENSBURY AVE.               SE DECISION MADE: 15-DEC-10

QUEENSBURY NY 12804               510(k) STATEMENT



DEVICE: EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475

VITAL DIAGNOSTICS (MANUFACTURING) 510(k) NO: K100060(TRADITIONAL)

ATTN: MELITA  LAMBIRIS            PHONE NO : 613 879 36300

189-199 BROWNS RD                 SE DECISION MADE: 15-DEC-10

NOBLE PARK, VICTORIA    AS 3174   510(k) STATEMENT



DEVICE: DEPUY GLOBAL UNITE SHOULDER SYSTEM

DEPUY (IRELAND)                   510(k) NO: K101996(TRADITIONAL)

ATTN: RHONDA  MYER                PHONE NO : 574 371 4927

LOUGHBEG RINGASKIDDY              SE DECISION MADE: 15-DEC-10

CO. CORK    EI                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CONTOURS LAPIDUS PLATING SYSTEM

ORTHOFIX INC.                     510(k) NO: K102201(TRADITIONAL)

ATTN: MARY  BIGGERS               PHONE NO : 972 824 4624   

1720 BRAY CENTRAL DR.             SE DECISION MADE: 15-DEC-10

MCKINNEY TX 75069                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING

KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K102956(SPECIAL)

ATTN: SHANNON  SCOTT              PHONE NO : 210 515 4368   

6203 FARINON DRIVE                SE DECISION MADE: 15-DEC-10

SAN ANTONIO TX 78249              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER

BIOLITEC, INC.                    510(k) NO: K102755(TRADITIONAL)

ATTN: NANCY  FOLEY                PHONE NO : 413 525 0600   

515 SHAKER RD.                    SE DECISION MADE: 16-DEC-10

EAST LONGMEADOW MA 01028          510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM

SYNTHES (USA)                     510(k) NO: K093299(TRADITIONAL)

ATTN: ALAN T HALEY                PHONE NO : 484 356 9763   

1301 GOSHEN PKWY.                 SE DECISION MADE: 16-DEC-10

WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE

MEDTRONIC INC.                    510(k) NO: K100646(TRADITIONAL)

ATTN: JEFFREY L KOLL              PHONE NO : 763 514 9842   

7611 NORTHLAND DRIVE              SE DECISION MADE: 16-DEC-10

MINNEAPOLIS MN 55428              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301

VASCULAR SOLUTIONS, INC.          510(k) NO: K101659(TRADITIONAL)

ATTN: MATT  NIENSTEDT             PHONE NO : 763 656 4300   

6464 SYCAMORE COURT               SE DECISION MADE: 16-DEC-10

MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: EUROMI EVA SP6

EUROMI SA                         510(k) NO: K101413(TRADITIONAL)

ATTN: CURTIS  RAYMOND             PHONE NO : 203 922 0105   

80 SHELTON TECHNOLOGY CENTER      SE DECISION MADE: 16-DEC-10

SHELTON CT 06484                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: GNR TRAFFIC LIGHT PNA FISH

ADVANDX, INC.                     510(k) NO: K101558(TRADITIONAL)

ATTN: HENRIK  STENDER             PHONE NO : 781 376 0009   

400 TRADECENTER SUITE 6990        SE DECISION MADE: 16-DEC-10

WOBURN MA 01801                   510(k) STATEMENT



DEVICE: VU CPOD INTERVERTEBRAL BODU FUSION DEVICE

MUSCULOSKELETAL CLINICAL REGULATOR510(k) NO: K101363(TRADITIONAL)

ATTN: GLENN  STIEGMAN             PHONE NO : 202 552 5800   

1331 H STREET NW, 12TH FLOOR      SE DECISION MADE: 16-DEC-10

WASHINGTON DC 20005               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ENDO FLIP

CROSPON, LTD.                     510(k) NO: K102214(TRADITIONAL)

ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   

24301 WOODSAGE DRIVE              SE DECISION MADE: 16-DEC-10

BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: POSTERIOR LATERAL PLATES

DEPUY ORTHOPAEDICS, INC.          510(k) NO: K103408(SPECIAL)

ATTN: SUZANA  OTANO               PHONE NO : 305 269 6386   

700 ORTHOPAEDIC DRIVE             SE DECISION MADE: 16-DEC-10

WARSAW IN 46581 0988              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PEAK PULSAR II GENERATOR MODEL PS100-102

PEAK SURGICAL, INC.               510(k) NO: K102029(SPECIAL)

ATTN: LOIS  NAKAYAMA              PHONE NO : 650 331 8920   

2464 EMBARCADERO WAY              SE DECISION MADE: 16-DEC-10

PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: AVITA WRIST TYPE BLOOD PRESSURE MONITOR

AVITA CORPORATION                 510(k) NO: K102624(TRADITIONAL)

ATTN: JENNIFER  REICH             PHONE NO : 928 863 6340   

2904 N. BOLDT DR.                 SE DECISION MADE: 16-DEC-10

FLAGSTAFF AZ 86001                510(k) STATEMENT



DEVICE: NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

MEDYSSEY CO., LTD.                510(k) NO: K103147(SPECIAL)

ATTN: PATRICK  MOORE              PHONE NO : 801 266 4811   

6170 SOUTH 380 WEST SUITE 200     SE DECISION MADE: 16-DEC-10

MURRAY UT 84107                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM

CARDINAL HEALTH, INC.             510(k) NO: K103249(TRADITIONAL)

ATTN: TATYANA  BOGDAN             PHONE NO : 847 887 2325   

1430 WAUKEGAN ROAD                SE DECISION MADE: 16-DEC-10

MCGAW PARK IL 60085               510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: GSP NEONATAL IRT KIT (3306-001U)

WALLAC OY, SUBSIDIARY OF PERKINELM510(k) NO: K102419(TRADITIONAL)

ATTN: SUSAN K HAMANN              PHONE NO : 781 663 5872   

940 WINTER STREET                 SE DECISION MADE: 16-DEC-10

WALTHAM MA 02451                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM

C.R. BARD INC                     510(k) NO: K102766(TRADITIONAL)

ATTN: KETI  SINO                  PHONE NO : 401 825 8575   

100 CROSSINGS BOULEVARD           SE DECISION MADE: 16-DEC-10

WARWICK RI 02886                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: STIMPOD NMS450 NERVE STIMULATOR

XAVANT TECHNOLOGY (PTY), LTD.     510(k) NO: K102084(TRADITIONAL)

ATTN: B  ROTHMAN                  PHONE NO : 271 275 59491

169 GARSFONTEIN ROAD ASHLEA GARDENSE DECISION MADE: 16-DEC-10

PRETORIA, GAUTENG    SF 0081      510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: EXPEDIUM SPINE SYSTEM

DEPUY SPINE, A JOHNSON & JOHNSON C510(k) NO: K102249(SPECIAL)

ATTN: DAPHNEY  GERMAIN            PHONE NO : 508 880 8395   

325 PARAMOUNT DRIVE               SE DECISION MADE: 16-DEC-10

RAYNHAM MA 02767                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE

THEKEN SPINE LLC                  510(k) NO: K102323(TRADITIONAL)

ATTN: DALE  DAVISON               PHONE NO : 330 475 8600   

1800 TRIPLETT BLVD.               SE DECISION MADE: 16-DEC-10

AKRON OH 44306                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: VIPI BLOCK

VIPI INDUSTRIA,COMERCIO,EXPORTACAO510(k) NO: K102341(TRADITIONAL)

ATTN: KEVIN  WALLS                PHONE NO : 720 962 5412   

5401 S. COTTONWOOD COURT          SE DECISION MADE: 16-DEC-10

GREENWOOD VILLAGE CO 80121        510(k) STATEMENT



DEVICE: IBED WIRELESS WITH IBED AWARENESS

STRYKER CORPORATION               510(k) NO: K103536(TRADITIONAL)

ATTN: DIANE  HORWITZ              PHONE NO : 703 307 2921   

3800 E. CENTRE AVE                SE DECISION MADE: 16-DEC-10

PORTAGE MI 49002                  510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: STRAUMANN MEMBRAGEL

STRAUMANN USA (ON BEHALF OF INSTIT510(k) NO: K101956(TRADITIONAL)

ATTN: JANET C KAY                 PHONE NO : 978 743 2575   

60 MINUTEMAN ROAD                 SE DECISION MADE: 16-DEC-10

ANDOVER MA 01810                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: HIGH PRESSURE SETS-400 PSI

ICU MEDICAL, INC.                 510(k) NO: K100576(TRADITIONAL)

ATTN: TRACY  BEST                 PHONE NO : 801 264 1332   

4455 ATHERTON DRIVE               SE DECISION MADE: 17-DEC-10

SALT LAKE CITY UT 84123           510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SMARTO

JEIL MEDICAL CORPORATION          510(k) NO: K101563(TRADITIONAL)

ATTN: KIM  SEONG NAM              PHONE NO : 822 838 5517

1006 DIGITAL 2CHA VALLEY BYUCKSAN,SE DECISION MADE: 17-DEC-10

SEOUL    KS                       510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: REGIONAL OXIMETER

NONIN MEDICAL, INC.               510(k) NO: K102715(TRADITIONAL)

ATTN: LORI M MITCHELL             PHONE NO : 763 577 3093   

13700 1ST AVE. NORTH              SE DECISION MADE: 17-DEC-10

PLYMOUTH MN 55441 5443            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE

PEAK SURGICAL, INC.               510(k) NO: K102709(SPECIAL)

ATTN: AN  NGUYEN                  PHONE NO : 650 331 3020   

2464 EMBARCADERO WAY              SE DECISION MADE: 17-DEC-10

PALO ALTO CA 94303                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

SIEMENS CORP.                     510(k) NO: K103360(TRADITIONAL)

ATTN: ROSE T MARINELLI            PHONE NO : 302 631 8805   

500 GBC DRIVE MAILSTOP 514 P.O. BOSE DECISION MADE: 17-DEC-10

NEWARK DE 19714                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NIHON KHDEN PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION

NIHON KOHDEN CORP.                510(k) NO: K102106(TRADITIONAL)

ATTN: STEVE  GEERDES              PHONE NO : 949 580 1555   

90 ICON STREET                    SE DECISION MADE: 17-DEC-10

FOOTHILL CA 92610                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: UNITY NETWORK ID

GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K103432(SPECIAL)

ATTN: ROBERT  CASARSA             PHONE NO : 414 362 3063   

8200 WEST TOWER AVENUE            SE DECISION MADE: 17-DEC-10

MILWAUKEE WI 53223                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER

INOVO, INC.                       510(k) NO: K103392(SPECIAL)

ATTN: MICHAEL T DILDINE           PHONE NO : 239 643 6577   

2975 S. HORSESHOE DRIVE SUITE 600 SE DECISION MADE: 17-DEC-10

NAPLES FL 34104                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939

HARDY DIAGNOSTICS                 510(k) NO: K103538(TRADITIONAL)

ATTN: WENDY  HADLEY               PHONE NO : 800 266 2222   

1430 WEST MCCOY LN.               SE DECISION MADE: 17-DEC-10

SANTA MARIA CA 93455              510(k) STATEMENT



DEVICE: ULTRASIGHT HD DIGITAL COLPOSCOPY WITH IMAGESENSE TECHNOLOGY

STI MEDICAL SYSTEMS               510(k) NO: K090324(TRADITIONAL)

ATTN: ROLF  WOLTERS               PHONE NO : 808 540 4728   

733 BISHOP STREET SUITE 3100      SE DECISION MADE: 20-DEC-10

HONOLULU HI 96813                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SYNTHES ZERO-P

SYNTHES SPINE                     510(k) NO: K093762(SPECIAL)

ATTN: AMNON  TALMOR               PHONE NO : 610 719 5446   

1302 WRIGHTS LANE EAST            SE DECISION MADE: 20-DEC-10

WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PT-MULTI-CALIBRATOR, MODEL OPAT07

DADE BEHRING, INC.                510(k) NO: K093848(TRADITIONAL)

ATTN: RADAMES  RIESGO             PHONE NO : 305 480 7558   

500 GBC DR, MAILSTOP 514          SE DECISION MADE: 20-DEC-10

NEWARK DE 19714 6101              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: COWELL IMPLANT SYSTEM

COWELLMEDI CO., LTD               510(k) NO: K100850(TRADITIONAL)

ATTN: JOYCE  BANG                 PHONE NO : 714 525 0114   

325 N. PUENTE ST UNIT B           SE DECISION MADE: 20-DEC-10

BREA CA 92821                     510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: INERTIA PEDICLE SCREW SYSTEM

NEXXT SPINE LLC                   510(k) NO: K101278(SPECIAL)

ATTN: KAREN  WARDEN               PHONE NO : 440 729 8457   

8202 SHERMAN ROAD                 SE DECISION MADE: 20-DEC-10

CHESTERLAND OH 44026 2141         510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ENDURO KNEE SYSTEM

AESCULAP IMPLANT SYSTEMS          510(k) NO: K101815(TRADITIONAL)

ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   

3773 CORPORATE PWKY.              SE DECISION MADE: 20-DEC-10

CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MINI AND  MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACE

NEOORTHO PRODUTOS ORTOPEDICOS S/A 510(k) NO: K102641(TRADITIONAL)

ATTN: LINDA K SCHULZ              PHONE NO : 858 791 1235   

11234 EL CAMINO REAL SUITE 200    SE DECISION MADE: 20-DEC-10

SAN DIEGO CA 92130                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

YOUNGSHENGPLASTIC CO., LTD        510(k) NO: K103198(TRADITIONAL)

ATTN: WU  WEI                     PHONE NO : 86 373 2588628

NEW INDUSTRIAL PARK               SE DECISION MADE: 20-DEC-10

XINCIANGCITY    CH 453003         510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PRELUDE II TOUNGE SUSPENSION SYSTEM

SIESTA MEDICAL, INC.              510(k) NO: K103179(SPECIAL)

ATTN: MICHAEL  KOLBER             PHONE NO : 408 505 6626   

101 CHURCH STREET SUITE 3         SE DECISION MADE: 20-DEC-10

LOS GATOS CA 95030                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: RHEAD RADIAL HEAD EXTENDED STEMS

SMALL BONE INNOVATIONS, INC.      510(k) NO: K102180(TRADITIONAL)

ATTN: JAMES  O'CONNOR             PHONE NO : 215 428 1791   

1380 S. PENNSYLVANIA AVE.         SE DECISION MADE: 20-DEC-10

MORRISVILLE PA 19067              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

ZIBO YUQUN NEW MATERIAL SCIENCE AN510(k) NO: K102724(TRADITIONAL)

ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   

12390 EST END AVE                 SE DECISION MADE: 20-DEC-10

CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON

HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K102889(TRADITIONAL)

ATTN: DOUGH  THISTLETHWAITE       PHONE NO : 330 425 1313   

1959 SUMMIT COMMERCE PARK         SE DECISION MADE: 20-DEC-10

TWINSBURG OH 44087                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DANA REUSABLE TEST PACK FOR STEAM STERILIZATION

DANA PRODUCTS, INC.               510(k) NO: K102761(TRADITIONAL)

ATTN: HARRY  BALA                 PHONE NO : 847 455 2881   

7 COREY DR.                       SE DECISION MADE: 20-DEC-10

SOUTH BARRINGTON IL 60010         510(k) STATEMENT



DEVICE: ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM

ACE SURGICAL SUPPLY COMPANY INC.  510(k) NO: K102981(SPECIAL)

ATTN: CAROL A HOUTS               PHONE NO : 508 588 3100   

1034 PEARL ST.                    SE DECISION MADE: 20-DEC-10

BROCKTON MA 02401                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SYNTHETIC, POWDER-FREE NITRILE EXAMINATION

ZIBO YINGHAO MEDICAL PRODUCTS CO.,510(k) NO: K102593(TRADITIONAL)

ATTN: FRANK  LIU                  PHONE NO : 909 548 4828   

12390 EAST END AVE                SE DECISION MADE: 20-DEC-10

CHINO CA 91710                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: TWISTCUT ENDOSORB SCREWS

MERETE MEDICAL GMBH               510(k) NO: K102777(TRADITIONAL)

ATTN: EMMANUEL  ANAPLIOTIS        PHONE NO : 914 967 1532

102 ALT LANKWITZ                  SE DECISION MADE: 20-DEC-10

BERLIN    GM D-12247              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C

INTEGRA LIFESCIENCES CORPORATION  510(k) NO: K102875(TRADITIONAL)

ATTN: DONNA  MILLISKY             PHONE NO : 609 936 2454   

311 ENTERPRISE DR.                SE DECISION MADE: 20-DEC-10

PLAINSBORO NJ 08536               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SUNMAX VIETNAM CO. LTD POWDER FREE WHITE NITRILE EXAMINATION GLOVE

SUNMAX VIETNAM CO. LTD            510(k) NO: K101870(ABBREVIATED)

ATTN: JIGAR  SHAH                 PHONE NO : 516 482 9001   

55 NORTHERN BLVD SUITE 200        SE DECISION MADE: 20-DEC-10

GREAT NECK NY 11021               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK

MEDACTA INTERNATIONAL, SA         510(k) NO: K103189(SPECIAL)

ATTN: NATALIE J KENNEL            PHONE NO : 858 705 0350   

13721 VIA TRES VISTA              SE DECISION MADE: 20-DEC-10

SAN DIEGO CA 92129                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM

SYNTHES (USA)                     510(k) NO: K102656(TRADITIONAL)

ATTN: ALAN T HALEY                PHONE NO : 484 356 9763   

1301 GOSHEN PKWY.                 SE DECISION MADE: 20-DEC-10

WEST CHESTER PA 19380             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: IMC PISTON SYRINGES

INTERNATIONAL MEDSURG CONNECTION  510(k) NO: K102969(SPECIAL)

ATTN: PETER  KIM                  PHONE NO : 847 619 9926   

935 N PLUM GROVE RD, STE F        SE DECISION MADE: 20-DEC-10

SCHAUMBURG IL 60173               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

HEZE JUXINYUAN FOOD CO., LTD      510(k) NO: K102977(TRADITIONAL)

ATTN: CHU  XIAOAN                 PHONE NO : 861 082 387441

RM 1606 BLD 1 JIAN XIANG YUAN N209SE DECISION MADE: 20-DEC-10

BEIJING    CH 100083              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS

COMED CO., LTD                    510(k) NO: K100703(TRADITIONAL)

ATTN: BRANDON  CHOI               PHONE NO : 714 523 1592   

49 CANDLEWOOD WAY                 SE DECISION MADE: 21-DEC-10

BUENA PARK CA 90621               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1315 A; AND MS-GDHC-1315J A, GAMCATH HIGH FLOW DOLPHIN MS-GDHC-1320 A; AND MS-GDHC-132

GAMBRO RENAL PRODUCTS, INC.       510(k) NO: K100451(TRADITIONAL)

ATTN: KAE  MILLER                 PHONE NO : 303 222 6724   

14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 21-DEC-10

LAKEWOOD CO 80401                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: COULTER LIN-X LINEARITY CONTROL, MODEL A81196

BECKMAN COULTER, INC.             510(k) NO: K100790(TRADITIONAL)

ATTN: LOURDES M COBA              PHONE NO : 305 380 4079   

11800 SW 147TH AVE.               SE DECISION MADE: 21-DEC-10

MIAMI FL 33196 2500               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K101715(TRADITIONAL)

ATTN: RANDOLPH  QUINN             PHONE NO : 781 699 9505   

920 WINTER STREET                 SE DECISION MADE: 21-DEC-10

WALTHAM MA 02451 1457             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: GEOSOURCE

ELECTRICAL GEODESICS, INC.        510(k) NO: K092844(TRADITIONAL)

ATTN: PAUL  HOLMAN                PHONE NO : 541 687 7962   

29611 SIMMONS ROAD                SE DECISION MADE: 21-DEC-10

EUGENE OR 97405                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CARRIGEN

ETEX CORP.                        510(k) NO: K100883(TRADITIONAL)

ATTN: CHRISTOPHER  KLACZYK        PHONE NO : 617 577 7270   

38 SIDNEY ST.                     SE DECISION MADE: 21-DEC-10

CAMBRIDGE MA 02139                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PC CARE BLOOD GLUCOSE DATA MANAGEMENT SOFTWARE

I-SENS, INC.                      510(k) NO: K100937(TRADITIONAL)

ATTN: HYUN  OH                    PHONE NO : 822 916 6191

465-6 WOLGYE-DONG, NOWON-GU       SE DECISION MADE: 21-DEC-10

SEOUL    KS 139-845               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LEKSELL GAMMAPLAN

ELEKTA INSTRUMENT AB              510(k) NO: K103093(TRADITIONAL)

ATTN: BO  NILSSON                 PHONE NO : 468 587 25400

KUNGSTENSGATAN 18 P.O.BOX 7593    SE DECISION MADE: 21-DEC-10

STOCKHOLM    SW S-103 93          510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001

VERIDEX, LLC                      510(k) NO: K103502(SPECIAL)

ATTN: SARAH  MCMANUS              PHONE NO : 908 704 3920   

1001 US HIGHWAY 202 NORTH         SE DECISION MADE: 21-DEC-10

RARITAN NJ 08869 0606             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: TARGON FN SYSTEM

AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K102057(TRADITIONAL)

ATTN: KATHY A RACOSKY             PHONE NO : 610 984 9291   

3773 CORPORATE PARKWAY            SE DECISION MADE: 21-DEC-10

CENTER VALLEY PA 18034            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS

ALERE, SAN DIEGO, DBA BIOSITE INCO510(k) NO: K102700(TRADITIONAL)

ATTN: EDWARD  BREHM               PHONE NO : 858 805 3071   

9975 SUMMERS RIDGE ROAD           SE DECISION MADE: 21-DEC-10

SAN DIEGO CA 92121                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY

ASCENSION ORTHOPEDICS, INC.       510(k) NO: K102549(TRADITIONAL)

ATTN: SUSAN  WALTON               PHONE NO : 512 836 5001   

8700 CAMERON RD., STE. 100        SE DECISION MADE: 21-DEC-10

AUSTIN TX 78754 3832              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS

ENCORE MEDICAL, L.P.              510(k) NO: K103223(TRADITIONAL)

ATTN: ALBERT E ALONSO             PHONE NO : 512 834 6235   

9800 METRIC BLVD.                 SE DECISION MADE: 21-DEC-10

AUSTIN TX 78758                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, "M" ADAPTER EX3180

ST JUDE MEDICAL, CRMD             510(k) NO: K101982(TRADITIONAL)

ATTN: GINA  CORREA                PHONE NO : 408 522 6775   

701 E. EVELYN AVENUE              SE DECISION MADE: 21-DEC-10

SUNNYVALE CA 94086                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MATRYX INTERFERENCE SCREW (5.0-6.5MM)

CONMED LINVATEC                   510(k) NO: K102410(TRADITIONAL)

ATTN: ASHLEA  BOWEN               PHONE NO : 727 399 5564   

11311 CONCEPT BOULEVARD           SE DECISION MADE: 21-DEC-10

LARGO FL 33773 4908               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: NEUROVISION SE (NERVEANA)

NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K102862(TRADITIONAL)

ATTN: CHRISTINE  VERGELY          PHONE NO : 866 815 6999   

2225 SPERRY AVE, SUITE 1000       SE DECISION MADE: 21-DEC-10

VENTURA CA 93003                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SONIXTABLET ULTRASOUND SCANNER

ULTRASONIX MEDICAL CORPORATION    510(k) NO: K102997(TRADITIONAL)

ATTN: CHAS  YU                    PHONE NO : 604 279 8550

130-4311 VIKING WAY               SE DECISION MADE: 21-DEC-10

RICHMOND, BRITISH COLUMBIA    CA V510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: FLEXTIME FAST & SCAN PUTTY, FLEXTIME FAST & SCAN LIGHT FLOW, FLEXTIME FAST & SCAN MEDIUM FLOW

HERAEUS KULZER, LLC               510(k) NO: K102770(TRADITIONAL)

ATTN: CHERYL  ZIMMERMAN           PHONE NO : 574 299 5444   

300 HERAEUS WAY                   SE DECISION MADE: 21-DEC-10

SOUTH BEND IN 46614               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: OSOM C. DIFFICILE TOXIN A/B TEST

GENZYME CORPORATION               510(k) NO: K102242(TRADITIONAL)

ATTN: CAROL C RYERSON             PHONE NO : 508 661 1154   

31 NEW YORK AVENUE                SE DECISION MADE: 21-DEC-10

FRAMINGHAM MA 01701               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: 2.6F X 20CM VASCU-PICC, 2.6F X 50CM VASCU-PICC

MEDCOMP                           510(k) NO: K102966(TRADITIONAL)

ATTN: JEAN  CALLOW                PHONE NO : 215 256 4201   

1499 DELP DR.                     SE DECISION MADE: 21-DEC-10

HARLEYSVILLE PA 19438             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE

MAGNATONE HEARING AID CORP. DBA PE510(k) NO: K093715(ABBREVIATED)

ATTN: DON  CAMPBELL               PHONE NO : 407 339 2422   

170 N. CYPRESS WAY                SE DECISION MADE: 22-DEC-10

CASSELBERRY FL 32707              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: REAVILLMED PRESSURE MONITORING SYSTEM AND PICC

REAVILLMED                        510(k) NO: K101189(TRADITIONAL)

ATTN: MICHELE H VOVOLKA           PHONE NO : 847 856 0355   

888 E. BELVIDERE ROAD SUITE 212   SE DECISION MADE: 22-DEC-10

GRAYSLAKE IL 60030                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE

STAAR JAPAN                       510(k) NO: K101782(SPECIAL)

ATTN: JACK  COGGAN                PHONE NO : 626 303 7902   

1911 WALKER AVENUE                SE DECISION MADE: 22-DEC-10

MONROVIA CA 91016                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES

HOWMEDICA OSTEONICS CORP.         510(k) NO: K102992(TRADITIONAL)

ATTN: AVITAL  MERL-MARGULIES      PHONE NO : 

325 CORPORATE DRIVE               SE DECISION MADE: 22-DEC-10

MAHWAH NJ 07430                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BARD DIGNISHELD STOOL MANAGEMENT SYSTEM

C.R. BARD, INC.                   510(k) NO: K102391(TRADITIONAL)

ATTN: SCOTT  PEASE                PHONE NO : 770 784 6774   

8195 INDUSTRIAL BLVD.             SE DECISION MADE: 22-DEC-10

MADISON GA 30014                  510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: NEO-SERVO I

ATOM MEDICAL CORPORATION          510(k) NO: K102710(TRADITIONAL)

ATTN: PAUL  DRYDEN                PHONE NO : 239 498 2155   

24301 WOODSTAGE DRIVE             SE DECISION MADE: 22-DEC-10

BONITA SPRINGS FL 34134           510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS

HINSON AND HALE MEDICAL TECHNOLOGI510(k) NO: K102783(TRADITIONAL)

ATTN: JEFFREY O STULL             PHONE NO : 512 288 8272   

7809 ADELAIDE DRIVE               SE DECISION MADE: 22-DEC-10

AUSTIN TX 78739                   510(k) STATEMENT



DEVICE: RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH

COLOPLAST A/S                     510(k) NO: K103568(SPECIAL)

ATTN: JANELL A COLLEY             PHONE NO : 612 287 4211   

1601 WEST RIVER ROAD NORTH        SE DECISION MADE: 22-DEC-10

MINNEAPOLIS MN 55411              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SIMPLYGO BREAST PUMP

EVENFLO COMPANY, INC.             510(k) NO: K102600(SPECIAL)

ATTN: AMY  NEFF                   PHONE NO : 937 415 3300   

225 BYERS RD.                     SE DECISION MADE: 22-DEC-10

MIAMISBURG OH 45342               510(k) STATEMENT



DEVICE: PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE

C.R. BARD INC                     510(k) NO: K103109(SPECIAL)

ATTN: DENNIS  SALZMANN            PHONE NO : 801 522 5432   

605 NORTH 5600 WEST               SE DECISION MADE: 22-DEC-10

SALT LAKE CITY UT 84116           510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ANTERIOR APPROACH HIP SURGERY INSTRUMENTS

WRIGHT MEDICAL TECHNOLOGY, INC.   510(k) NO: K102565(SPECIAL)

ATTN: GREGORY  NEAL               PHONE NO : 901 867 5812   

5677 AIRLINE RD.                  SE DECISION MADE: 22-DEC-10

ARLINGTON TN 38002                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MAHURKAR TRIPLE LUMEN DIALYSIS CATHETER

COVIDIEN LLC, FORMERLY REGISTERED 510(k) NO: K102605(TRADITIONAL)

ATTN: DANIEL  CAMPION             PHONE NO : 508 452 4135   

15 HAMPSHIRE ST.                  SE DECISION MADE: 22-DEC-10

MANSFIELD MA 02048                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PULSE OXIMETER

NONIN MEDICAL, INC.               510(k) NO: K102350(TRADITIONAL)

ATTN: LORI M MITCHELL             PHONE NO : 763 577 3093   

13700 1ST AVE. NORTH              SE DECISION MADE: 22-DEC-10

PLYMOUTH MN 55441 5443            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: THERMAL MASSAGE BED, MODEL 2D-GX

INAREX CORPORATION                510(k) NO: K102281(SPECIAL)

ATTN: EILEEN  YANG                PHONE NO : 82 42 4762977

MIGUN TECHNO WORLD 2 C-DONG 2 C-DOSE DECISION MADE: 22-DEC-10

YUSEONG-GU, DAEJON    KS 533-1    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PRONTO V4 EXTRACTION CATHETER 5.5F; PRONTO V4 EXTRACTION CATHETER 6F; PRONTO V4 EXTRACTION 7F; PRONTO V4 EXTRACTION CATH

VASCULAR SOLUTIONS, INC.          510(k) NO: K103405(SPECIAL)

ATTN: MATT  NIENSTEDT             PHONE NO : 763 656 4300   

6464 SYCAMORE COURT               SE DECISION MADE: 22-DEC-10

MINNEAPOLIS MN 55369              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ESPRIT VENTILATOR WITH APRV OPTION, V200 VENTILATOR WITH APRV OPTION, MODELS V1000, V200

RESPIRONICS CALIFORNIA, INC.      510(k) NO: K102054(TRADITIONAL)

ATTN: TAMATHA  LEY                PHONE NO : 760 918 1026   

2271 COSMOS CT.                   SE DECISION MADE: 22-DEC-10

CARLSBAD CA 92011                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LIFEPAK 12

PHYSIO-CONTROL, INC.              510(k) NO: K102972(SPECIAL)

ATTN: MICHELLE  ACKERMANN         PHONE NO : 425 867 4744   

11811 WILLOWS ROAD NORTHEAST P.O. SE DECISION MADE: 22-DEC-10

REDMOND WA 98073 9706             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM

TRUEVISION SYSTEMS, INCORPORATED  510(k) NO: K101861(TRADITIONAL)

ATTN: BURTON  TRIPATHI            PHONE NO : 805 963 9709   

114 EAST HALEY STREET, SUITE L    SE DECISION MADE: 22-DEC-10

SANTA BARBARA CA 93101            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PROLONG, MODELS PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,

LIFE-TECH, INC.                   510(k) NO: K102007(SPECIAL)

ATTN: JEFF  KASOFF                PHONE NO : 281 491 6600   

13235 NORTH PROMENADE BLVD.       SE DECISION MADE: 22-DEC-10

STAFFORD TX 77477                 510(k) STATEMENT



DEVICE: AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM

QUANTEL MEDICAL S.A.              510(k) NO: K102027(TRADITIONAL)

ATTN: MICHAEL  JOHNSON            PHONE NO : 406 586 0131   

601 HAGGERTY LANE                 SE DECISION MADE: 22-DEC-10

BOZEMAN MT 59715                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: 31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T

RAPID BIOMEDICAL GMBH             510(k) NO: K102348(ABBREVIATED)

ATTN: ARMIN  PUREA                PHONE NO : 499 365 88260

KETTELERSTR. 3-11                 SE DECISION MADE: 22-DEC-10

RIMPAR, BAVARIA    GM 97222       510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MI VARNISH

GC AMERICA INC.                   510(k) NO: K102808(TRADITIONAL)

ATTN: MARK  HEISS                 PHONE NO : 708 897 4042   

3737 WEST 127TH STREET            SE DECISION MADE: 22-DEC-10

ALSIP IL 60803                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: GOLIFE NASAL MASK

RESPIRONICS, INC.                 510(k) NO: K102502(SPECIAL)

ATTN: MICHELLE  BRINKER           PHONE NO : 724 387 4146   

365 PLUM INDUSTRIAL COURT         SE DECISION MADE: 22-DEC-10

PITTSBURGH PA 15239               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: RESOLUTION II CLIP

BOSTON SCIENTIFIC CORPORATION     510(k) NO: K102764(TRADITIONAL)

ATTN: ELENA  NIEVES               PHONE NO : 508 683 4347   

100 BOSTON SCIENTIFIC WAY         SE DECISION MADE: 22-DEC-10

MARLBOROUGH MA 01752              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: PACIFIC XTREME PTCA BALLOON DILATATION CATHETER

MEDTRONIC INC.                    510(k) NO: K103464(SPECIAL)

ATTN: HEATHER  MOROSE             PHONE NO : 978 739 3187   

37A CHERRY HILL DRIVE             SE DECISION MADE: 22-DEC-10

DANVERS MA 01923                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ARTHREX UNIVERS II SHOULDER PROSTHESIS

ARTHREX, INC.                     510(k) NO: K103466(SPECIAL)

ATTN: SALLY  FOUST, RAC           PHONE NO : 239 643 5553   

1370 CREEKSIDE BLVD.              SE DECISION MADE: 22-DEC-10

NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030

CAS MEDICAL SYSTEMS, INC.         510(k) NO: K094030(TRADITIONAL)

ATTN: RON  JEFFREY                PHONE NO : 203 488 6056   

44 EAST INDUSTRIAL RD.            SE DECISION MADE: 23-DEC-10

BRANFORD CT 06405                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5

AALTO SCIENTIFIC LTD.             510(k) NO: K100715(TRADITIONAL)

ATTN: BRANDON J PEREZ             PHONE NO : 760 431 7922   

1959 KELLOGG AVE.                 SE DECISION MADE: 23-DEC-10

CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ULTRA SEAL STERILE LUBRICATING JELLY

ULTRA SEAL CORPORATION            510(k) NO: K101522(TRADITIONAL)

ATTN: JAMES  DAVIS                PHONE NO : 845 255 2490   

521 MAIN STREET                   SE DECISION MADE: 23-DEC-10

NEW PALTZ NY 12561                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: AUDIT MICROCV HS-CRP LINEARITY SET

AALTO SCIENTIFIC LTD.             510(k) NO: K101427(TRADITIONAL)

ATTN: DESSI  LYAKOV               PHONE NO : 760 431 7922   

1959 KELLOGG AVE.                 SE DECISION MADE: 23-DEC-10

CARLSBAD CA 92008                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS

KIMBERLY-CLARK CORP.              510(k) NO: K103406(TRADITIONAL)

ATTN: DAVID M LEE                 PHONE NO : 770 587 7167   

1400 HOLCOMB BRIDGE RD. BLDG 300, SE DECISION MADE: 23-DEC-10

ROSWELL GA 30076 2199             510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: NYDIAG 200

INTERACOUSTICS A/S                510(k) NO: K102364(TRADITIONAL)

ATTN: ERIK  NIELSEN               PHONE NO : 456 371 3555

DREJERVAENGET 8                   SE DECISION MADE: 23-DEC-10

ASSENS    DA DK-5610              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MODEL LUNA MANUAL WHEELCHAIR

P.D.G., INC.                      510(k) NO: K102910(TRADITIONAL)

ATTN: EDWARD A KROLL              PHONE NO : 440 546 9810   

5905 FAWN LANE                    SE DECISION MADE: 23-DEC-10

CLEVELAND OH 44141                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: COMPACT WHEELCHAIR PLATFORM

DESIGN SPECIFIC FLETCHER          510(k) NO: K101723(TRADITIONAL)

ATTN: RICHARD  FLETCHER           PHONE NO : 

UNIT 10 CABURN ENTERPRISE PARK THESE DECISION MADE: 23-DEC-10

RINGMER EAST SUSSEX    UK BN8 5NP 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MODEL LA-1200 MULTI-CHANNEL LASER THERAPY SYSTEM

UNITED INTEGRATED SERVICES CO., LT510(k) NO: K102134(TRADITIONAL)

ATTN: DAVID O CHANG               PHONE NO : 886 2 29170366

PAOCHIAO ROAD 8F, # 4, ALLEY 1, LNSE DECISION MADE: 23-DEC-10

HSINTIEN CITY, TAIPEI HSIEN    TW 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5

ROCHE DIAGNOSTICS                 510(k) NO: K103221(TRADITIONAL)

ATTN: KELLY C O'MAINE ADAMS       PHONE NO : 317 521 3577   

9115 HAGUE ROAD P.O. BOX 50416    SE DECISION MADE: 23-DEC-10

INDIANAPOLIS IN 46250 0416        510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE

CROSSTEX INTERNATIONAL, INC.      510(k) NO: K103303(TRADITIONAL)

ATTN: RICHARD M ORMSBEE           PHONE NO : 763 551 2689   

14605 28TH AVENUE NORTH           SE DECISION MADE: 23-DEC-10

MINNEAPOLIS MN 55447              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: TSRH SPINAL SYSTEM

MEDTRONIC SOFAMOR DANEK           510(k) NO: K103049(SPECIAL)

ATTN: LILA  JOE                   PHONE NO : 901 396 3133   

1800 PYRAMID PLACE                SE DECISION MADE: 23-DEC-10

MEMPHIS TN 38132                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ERBEFLO 2 DISPOSABLE TUBING SYSTEM

ERBE USA, INC.                    510(k) NO: K103235(TRADITIONAL)

ATTN: JOHN  TARTAL                PHONE NO : 770 955 4400   

2225 NORTHWEST PKWY.              SE DECISION MADE: 23-DEC-10

MARIETTA GA 30067                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: 3.0T METAFLEXCOIL

NEOCOIL, LLC                      510(k) NO: K103342(TRADITIONAL)

ATTN: BRIAN  BROWN                PHONE NO : 262 347 1250   

N27 W23910A PAUL RD.              SE DECISION MADE: 23-DEC-10

PEWAUKEE WI 53072                 510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: US ENDOSCOPY CYTOLOGY BRUSH

UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103437(SPECIAL)

ATTN: CARROLL L MARTIN            PHONE NO : 440 639 4494   

5976 HEISELY RD.                  SE DECISION MADE: 23-DEC-10

MENTOR OH 44060                   510(k) STATEMENT



DEVICE: HIROLLER ELEVATING WHEELCHAIR

MAX MOBILITY, LLC                 510(k) NO: K102837(TRADITIONAL)

ATTN: WILLIAM M RICHTER           PHONE NO : 615 731 1860   

5425 MOUNT VIEW PARKWAY           SE DECISION MADE: 23-DEC-10

ANTIOCH TN 37013                  510(k) STATEMENT



DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

HEBEI HONGTAI PLASTIC PRODUCTS CO.510(k) NO: K102817(TRADITIONAL)

ATTN: RICHARD  LU                 PHONE NO : 861 064 796097

ROOM 3-402, NO 71 MAJIAPU YANGQIAOSE DECISION MADE: 23-DEC-10

BEIJING    CH 100068              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES

HEBEI HONGTAI PLASTIC PRODUCTS CO.510(k) NO: K102819(TRADITIONAL)

ATTN: RICHARD  LU                 PHONE NO : 861 064 796097

ROOM 3-402, NO 71 MAJIAPU YANGQIAOSE DECISION MADE: 23-DEC-10

BEIJING    CH 100068              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DEFOGGING AND CLEANING SOLUTION- FLO-X

MINIMALLY INVASIVE DEVICES LLC    510(k) NO: K102452(TRADITIONAL)

ATTN: MARK L FRIEDMAN, PH.D       PHONE NO : 352 275 7929   

6329 SW 81ST ROAD                 SE DECISION MADE: 23-DEC-10

LAKE BUTLER FL 32054              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: INCLUSIVE MINI IMPLANT

PRISMATIK DENTALCRAFT, INC.       510(k) NO: K100932(ABBREVIATED)

ATTN: KEITH  ALLRED               PHONE NO : 949 399 1732   

4141 MACARTHUR BLVD               SE DECISION MADE: 27-DEC-10

NEWPORT BEACH CA 92660            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: IYUNNI 3ID SUPRAPUBIC CYSTOSTOMY TUBE KIT

SAINATH INTELLECTUAL PROPERTIES, L510(k) NO: K102572(TRADITIONAL)

ATTN: CHRISTOPHER  PARADIES, PH.D.PHONE NO : 813 222 1190   

501 E KENNEDY BLVD. SUITE 1700    SE DECISION MADE: 27-DEC-10

TAMPA FL 33602                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DOSEVIEW 3D

STANDARD IMAGING, INC.            510(k) NO: K103193(TRADITIONAL)

ATTN: RAYMOND T RIDDLE            PHONE NO : 608 831 0025   

3120 DEMING WAY                   SE DECISION MADE: 27-DEC-10

MIDDLETON WI 53562 1461           510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: I3 SYSTEM-ABD DIAGNOSTIC ULTRASOUND

ELLEX, INC.                       510(k) NO: K103608(SPECIAL)

ATTN: JONATHAN  STRAWN            PHONE NO : 916 363 0774   

9940 BUSINESS PARK DR. SUITE 165  SE DECISION MADE: 27-DEC-10

SACRAMENTO CA 95827               510(k) STATEMENT



DEVICE: MEDISTIM VERIQC SYSTEM

MEDI-STIM ASA                     510(k) NO: K102595(TRADITIONAL)

ATTN: CONSTANCE G BUNDY           PHONE NO : 763 574 1976   

435 RICE CREEK TERRACE NE         SE DECISION MADE: 27-DEC-10

FRIDLEY MN 55432                  510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)

C.R. BARD, INC.                   510(k) NO: K103359(SPECIAL)

ATTN: CINDY  MOSS                 PHONE NO : 480 379 2836   

1415 W 3RD STREET                 SE DECISION MADE: 27-DEC-10

TEMPE AZ 85281                    510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DIGITAL DIAGNOSTIC X-RAY SYSTEM

DRGEM CORPORATION                 510(k) NO: K102408(TRADITIONAL)

ATTN: CHARLIE  MACK               PHONE NO : 541 376 5063   

77325 JOYCE WAY                   SE DECISION MADE: 27-DEC-10

EHCO OR 97826                     510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LIFEBRIDGE

LIFEBRIDGE MEDIZINTECHNIK AG      510(k) NO: K103357(SPECIAL)

ATTN: KATHLEEN  JOHNSON           PHONE NO : 610 527 0585   

1282 ROUND HILL RD.               SE DECISION MADE: 27-DEC-10

BRYN MAWR PA 19010                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: OSTEOPHIL BETA-TCP

CYTOPHIL INC                      510(k) NO: K102937(TRADITIONAL)

ATTN: VICTOR M BOWERS             PHONE NO : 262 642 2765   

2485 CORPORATE CIRCLE SUITE 2     SE DECISION MADE: 27-DEC-10

EAST TROY WI 53120                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM

SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K103583(TRADITIONAL)

ATTN: ZHAI  PEI                   PHONE NO : 867 558 1885604

MINDRAY BLDG. KEJI 12TH RD S. HI-TSE DECISION MADE: 27-DEC-10

SHENZHEN, GUANGDONG    CH 518057  510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: INCLUSIVE TITANIUM ABUTMENTS FOR ASTRA TECH OSSEOSPEED IMPLANTS

PRISMATIK DENTALCRAFT, INC.       510(k) NO: K100993(ABBREVIATED)

ATTN: KEITH  ALLRED               PHONE NO : 949 440 2683   

4141 MACARTHUR BLVD.              SE DECISION MADE: 28-DEC-10

NEWPORT BEACH CA 92660            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: MIRAGE FX

RESMED LTD.                       510(k) NO: K102746(TRADITIONAL)

ATTN: DAVID  D'CRUZ               PHONE NO : 858 836 5984   

9001 SPECTRUM CENTER BLVD.        SE DECISION MADE: 28-DEC-10

SAN DIEGO CA 92123                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ACL TIGHTROPE DOUBLE BUNDLE

ARTHREX, INC.                     510(k) NO: K101837(TRADITIONAL)

ATTN: GEENA  AUGUSTINE            PHONE NO : 239 643 5553   

1370 CREEKSIDE BLVD.              SE DECISION MADE: 28-DEC-10

NAPLES FL 34108 1945              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY; LZI AMPHETAMINES 500 CALIBRATORS; LZI AMPHETAMINES 500 CONTROLS

LIN-ZHI INTERNATIONAL, INC.       510(k) NO: K102210(TRADITIONAL)

ATTN: BERNICE  LIN                PHONE NO : 408 732 3856   

670 ALMANOR AVENUE                SE DECISION MADE: 28-DEC-10

SUNNYVALE CA 94085                510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: SAPPHIRE ST PORTABLE DIODE LASER

DEN-MAT HOLDINGS, LLC             510(k) NO: K103667(TRADITIONAL)

ATTN: ALAN B MATTHEWS             PHONE NO : 805 922 8491   

2727 SKYWAY DR.                   SE DECISION MADE: 29-DEC-10

SANTA MARIA CA 93455              510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: INCU I

ATOM MEDICAL CORPORATION          510(k) NO: K102279(TRADITIONAL)

ATTN: TSUYOSHI  SUGINO            PHONE NO : 813 381 53632

3-18-15 HONGO                     SE DECISION MADE: 29-DEC-10

BUNKYO-KU, TOKYO    JA 113-0033   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: ZENIUS SPINAL SYSTEM

MEDYSSEY CO., LTD.                510(k) NO: K103272(SPECIAL)

ATTN: PATRICK  MOORE              PHONE NO : 801 266 4811   

6170 SOUTH 380 WEST SUITE 200     SE DECISION MADE: 29-DEC-10

MURRAY UT 84107                   510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: INFRARED EAR THERMOMETER

RADIANT INNOVATION, INC.          510(k) NO: K103097(SPECIAL)

ATTN: JAMES  HUANG                PHONE NO : 886 361 11666

1F,NO. 3,INDUSTRIAL E. 9TH RD SCIESE DECISION MADE: 29-DEC-10

HSINCHU    TW 300                 510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: CANTATA MICROCATHETER

COOK, INC.                        510(k) NO: K101450(SPECIAL)

ATTN: MIRONDA  CARPENTER          PHONE NO : 812 339 2235   

750 DANIELS WAY P.O. BOX 489      SE DECISION MADE: 30-DEC-10

BLOOMINGTON IN 47402              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER

ABBOTT VASCULAR-CARDIAC THERAPIES 510(k) NO: K103153(TRADITIONAL)

ATTN: SUZANNE  REDMAN             PHONE NO : 951 914 3243   

26531 YNEZ RD. MAILING P.O. BOX 90SE DECISION MADE: 30-DEC-10

TEMECULA CA 92589 9018            510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: AED RESECTOSCOPE

NATIONAL ADVANCED ENDOSCOPY DEVICE510(k) NO: K102663(TRADITIONAL)

ATTN: GAYLE  BUTLER               PHONE NO : 818 227 2720   

22134 SHERMAN WAY                 SE DECISION MADE: 30-DEC-10

CANOGA PARK CA 91303              510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: G-CINCH SUTURE GRASPER

USGI MEDICAL                      510(k) NO: K102931(TRADITIONAL)

ATTN: MARY LOU  MOONEY            PHONE NO : 949 369 3890   

1140 CALLE CORDILLERA             SE DECISION MADE: 30-DEC-10

SAN CLEMENTE CA 92673             510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: IRRIGATION SYSTEM

UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103239(TRADITIONAL)

ATTN: CARROLL L MARTIN            PHONE NO : 440 639 4494   

5976 HEISELY RD.                  SE DECISION MADE: 30-DEC-10

MENTOR OH 44060                   510(k) STATEMENT



DEVICE: C-MAX, C-MAX U1, C-MAX U1 160KG, C-MAX U2, C-MAX U2 160KG, S-MAX, S-MAX AVIATION, S-MAX SELLA, S-MAX SELLA 160KG

AAT ALBER ANTRIEBSTECHNIK GMBH    510(k) NO: K103122(TRADITIONAL)

ATTN: STEFANIE D BANKSTON         PHONE NO : 409 229 0022   

2611 SHARK CIRCLE                 SE DECISION MADE: 30-DEC-10

TEXAS CITY TX 77591               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: BNX FINE NEEDLE ASPIRATION SYSTEM

BOSTON ENDOSCOPIC ENGINEERING     510(k) NO: K103668(TRADITIONAL)

ATTN: ANNETTE M FAGNANT           PHONE NO : 401 392 0287   

53 KENNEDY ROAD                   SE DECISION MADE: 30-DEC-10

FOSTER RI 02825                   510(k) SUMMARY AVAILABLE FROM FDA

                                  THIRD PARTY REVIEW



DEVICE: NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

SMART MEDICAL SYSTEMS, LTD.       510(k) NO: K102616(TRADITIONAL)

ATTN: ADVA  YOSELZON              PHONE NO : 972 9 7444478

10 HAYETSIRA STREET               SE DECISION MADE: 30-DEC-10

RAANANA    IS 43663               510(k) SUMMARY AVAILABLE FROM FDA



DEVICE: AXIOM FASCIAL CLOSURE SYSTEM

AXIOM TECHNOLOGY PARTNERS, LLC    510(k) NO: K103412(TRADITIONAL)

ATTN: RICHARD  RUSH               PHONE NO : 650 595 1104   

2939 ALHAMBRA DRIVE               SE DECISION MADE: 30-DEC-10

BELMONT CA 94002                  510(k) SUMMARY AVAILABLE FROM FDA





                                                 TOTAL 510(k)s THIS PERIOD   294                                     

                                                 TOTAL WITH SUMMARIES        271                                     

                                                 TOTAL WITH STATEMENTS        23

                                      

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Gift Bans

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