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
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