April 2011 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2011
DEVICE: VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM
C.R. BARD, INC. 510(k) NO: K110820(SPECIAL)
ATTN: KETI SINO PHONE NO : 401 825 8575
100 CROSSINGS BOULEVARD SE DECISION MADE: 01-APR-11
WARWICK RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSSEOTITE II MODEL XIFOSSXXX
BIOMET 3I, INC. 510(k) NO: K100724(TRADITIONAL)
ATTN: JOSE E CABRERA PHONE NO : 561 776 6840
4555 RIVERSIDE DR. SE DECISION MADE: 01-APR-11
PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
CEDARS-SINAI MEDICAL CENTER 510(k) NO: K100714(TRADITIONAL)
ATTN: DAVID R DILLS PHONE NO : 904 519 8040
8787 SOUTHSIDE BLVD., #719 SE DECISION MADE: 01-APR-11
JACKSONVILLE FL 32256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPRESSYN BAND
DALLEN MEDICAL 510(k) NO: K101484(TRADITIONAL)
ATTN: AL MEMMOLO PHONE NO : 949 218 0030
1046 CALLE RECODO SUITE G SE DECISION MADE: 01-APR-11
SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
ACCLARENT, INC. 510(k) NO: K103595(TRADITIONAL)
ATTN: GURVINDER SINGH NANDA PHONE NO : 650 687 5414
1525-B O'BRIEN DR. SE DECISION MADE: 01-APR-11
MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
CONSENSUS ORTHOPEDICS, INC. 510(k) NO: K110542(TRADITIONAL)
ATTN: MATTHEW HULL PHONE NO : 916 355 7100
1115 WINDFIELD WAY, SUITE 100 SE DECISION MADE: 01-APR-11
EL DORADO HILLS CA 95762 9623 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPEDIUM SYSTEM, VIPER SYSTEM
DEPUY SPINE, INC. 510(k) NO: K110216(SPECIAL)
ATTN: EUGENE BANG PHONE NO : 508 977 3966
325 PARAMOUNT DR. SE DECISION MADE: 01-APR-11
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110522(SPECIAL)
ATTN: NICHOLAS TABRIZI PHONE NO : 901 396 3133
1800 PYRAMID PLACE SE DECISION MADE: 01-APR-11
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL
GE MEDICAL SYSTEMS, LLC 510(k) NO: K110610(SPECIAL)
ATTN: MICHELLE SCHEIDT PHONE NO : 262 521 6102
3200 N. GRANDVIEW BLVD. SE DECISION MADE: 01-APR-11
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYLATOPICPLUS CREAM
PRECISION DERMATOLOGY INCORPORATED510(k) NO: K110727(SPECIAL)
ATTN: RONALD M GURGE PHONE NO : 401 762 2000
900 HIGHLAND CORPORATE DRIVE SE DECISION MADE: 01-APR-11
CUMBERLAND RI 02864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
ABBOT LABORATORIES 510(k) NO: K102699(TRADITIONAL)
ATTN: JUDITH WALLACH PHONE NO : 847 937 1132
100 ABBOTT PARK RD. DEPT. 9V6 AP6CSE DECISION MADE: 01-APR-11
ABBOTT PARK IL 60064 6092 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
EXACTECH, INC. 510(k) NO: K110708(SPECIAL)
ATTN: LINDY KNISELY PHONE NO : 352 377 1140
2320 N.W. 66TH CT. SE DECISION MADE: 01-APR-11
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALYTE Y-MESH GRAFT
C.R. BARD, INC. 510(k) NO: K101722(TRADITIONAL)
ATTN: SCOTT ROBIRDS PHONE NO : 770 784 6722
8195 INDUSTRIAL BLVD. SE DECISION MADE: 01-APR-11
COVINGTON GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD SEALSURE CHEMICAL INDICATOR TAPE
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K103219(TRADITIONAL)
ATTN: NANCY CHU PHONE NO : 949 453 6435
33 TECHNOLOGY DR. SE DECISION MADE: 01-APR-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERRAD CHEMICAL INDICATOR STRIP
ADVANCED STERILIZATION PRODUCTS 510(k) NO: K103218(TRADITIONAL)
ATTN: NANCY CHU PHONE NO : 949 453 6435
33 TECHNOLOGY DR. SE DECISION MADE: 01-APR-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORFLEX TRANSSEPTAL GUIDING SHEATH
BAYLIS MEDICAL CO., INC. 510(k) NO: K102948(TRADITIONAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875
2645 MATHESON BLVD. E SE DECISION MADE: 01-APR-11
MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
RESTORATION ROBOTICS, INC 510(k) NO: K103428(TRADITIONAL)
ATTN: KIT CARIQUITAN PHONE NO : 408 400 0856
155-A MOFFETT PARK DRIVE SUITE 210SE DECISION MADE: 04-APR-11
SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
MEDICA CORP. 510(k) NO: K101088(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781 275 4892
5 OAK PARK DRIVE SE DECISION MADE: 04-APR-11
BEDFORD MA 01730 510(k) STATEMENT
DEVICE: NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
TANGSHAN BAOJIE GLOVE CO., LTD 510(k) NO: K110185(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG1.JIANXIANG YUAN NO.SE DECISION MADE: 04-APR-11
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL FOREHEAD THERMOMETER
K-JUMP HEALTH CO., LTD. 510(k) NO: K103617(SPECIAL)
ATTN: JASON CHENG PHONE NO : 886 222 991378
NO. 56, WU KUNG 5TH RD., WU KU INDSE DECISION MADE: 04-APR-11
TAIPEI HSIEN TW 248 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED HD GUIDE CATHETER
CONCENTRIC MEDICAL, INC. 510(k) NO: K110483(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650 810 1707
301 E. EVELYN AVE. SE DECISION MADE: 04-APR-11
MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAULT ALIF SYSTEM
SPINAL USA 510(k) NO: K103369(TRADITIONAL)
ATTN: LINDA POLK PHONE NO : 601 420 4244
2050 EXECUTIVE DR. SE DECISION MADE: 04-APR-11
PEARL MS 39208 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RT600
RESTORATIVE THERAPIES INC. 510(k) NO: K103366(TRADITIONAL)
ATTN: SCOTT SIMCOX PHONE NO : 800 609 9166
907 SOUTH LAKEWOOD AVE. SE DECISION MADE: 04-APR-11
BALTIMORE MD 21224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KNEEALIGN SYSTEM
ORTHALIGN, INC 510(k) NO: K103829(TRADITIONAL)
ATTN: AMY WALTERS PHONE NO : 949 923 9400
338 VISTA MADERA SE DECISION MADE: 04-APR-11
NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
SOUND SURGICAL TECHNOLOGIES LLC. 510(k) NO: K110255(TRADITIONAL)
ATTN: STEPHEN C SMITH PHONE NO : 720 240 2970
357 S. MCCASLIN BLVD. #100 SE DECISION MADE: 04-APR-11
LOUISVILLE CO 80027 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CARDIOHELP SYSTEM
MAQUET CARDIOPULMONARY AG 510(k) NO: K102726(TRADITIONAL)
ATTN: ROLAND JEHLE PHONE NO : 004 974 78921373
HECHINGER STRASSE 38 SE DECISION MADE: 04-APR-11
HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAINLAB KNEE
BRAINLAB AG 510(k) NO: K102990(SPECIAL)
ATTN: ALEXANDER SCHWIERSCH PHONE NO : 498 999 15680
KAPELLENSTRASSE 12 SE DECISION MADE: 04-APR-11
FELDKIRCHEN GM 85622 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPRESSION COMPOUND
SPOFADENTAL 510(k) NO: K110378(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 05-APR-11
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
CHURCH & DWIGHT CO., INC. 510(k) NO: K100767(TRADITIONAL)
ATTN: JOSEPH CICCONE PHONE NO : 609 497 7251
469 NORTH HARRISON STREET SE DECISION MADE: 05-APR-11
PRINCETON NJ 08543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1
SALIENT SURGICAL TECHNOLOGIES 510(k) NO: K101057(TRADITIONAL)
ATTN: KERRI MORTON PHONE NO : 603 742 1515
180 INTERNATIONAL DRIVE SE DECISION MADE: 05-APR-11
PORTSMOUTH NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CUTERA GENESISPLUS LASER SYSTEM
CUTERA, INC. 510(k) NO: K103626(TRADITIONAL)
ATTN: CONNIE HOY PHONE NO : 415 657 5592
3240 BAYSHORE BLVD SE DECISION MADE: 05-APR-11
BRISBANE CA 94005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
TORNIER, INC. 510(k) NO: K103262(TRADITIONAL)
ATTN: HOWARD L SCHRAYER PHONE NO : 609 924 9510
100 CUMMINGS CENTER SUITE 444C SE DECISION MADE: 05-APR-11
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS
RESPIRONICS CALIFORNIA, INC. 510(k) NO: K102985(TRADITIONAL)
ATTN: TAMATHA LEY PHONE NO : 760 918 1026
2271 COSMOS CT. SE DECISION MADE: 05-APR-11
CARLSBAD CA 92011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRITY SPINAL CARE SYSTEM
INTEGRA LIFE SCIENCES 510(k) NO: K103248(TRADITIONAL)
ATTN: JAMES J GIBSON PHONE NO : 702 997 7190
5795 SOUTH SANDHILL ROAD SUITE F, SE DECISION MADE: 05-APR-11
LAS VEGAS NV 89120 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RT200
RESTORATIVE THERAPIES INC. 510(k) NO: K103370(TRADITIONAL)
ATTN: ANDREW BARRISKILL PHONE NO : 800 609 9166
907 SOUTH LAKEWOOD AVE. SE DECISION MADE: 05-APR-11
BALTIMORE MD 21224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL LA POSITIVE CONTROL
INSTRUMENTATION LABORATORY CO. 510(k) NO: K102552(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781 861 4467
180 HARTWELL ROAD SE DECISION MADE: 05-APR-11
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTELITE COLOR
TOKUYAMA DENTAL CORPORATION 510(k) NO: K110178(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202 783 5070
1425 K STREET, N.W. SUITE 1100 SE DECISION MADE: 05-APR-11
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHARPS CONTAINER
NOBLE MARKETING 510(k) NO: K110262(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317 569 9500
11460 N. MERIDIAN ST. SUITE 150 SE DECISION MADE: 05-APR-11
CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: REVERSE MEDICAL REFLEX GUIDE CATHETER
REVERSE MEDICAL CORPORATION 510(k) NO: K110055(TRADITIONAL)
ATTN: AMY ESKINA PHONE NO : 949 215 0660
13900 ALTON PARKWAY SUITE 123 SE DECISION MADE: 05-APR-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TEMPOROMANIBULAR COIL 15
ESAOTE S.P.A. 510(k) NO: K110373(TRADITIONAL)
ATTN: DONATELLA RAGGHIANTI PHONE NO : 011 390 106547259
VIA SIFFREDI 58 SE DECISION MADE: 06-APR-11
GENOVA IT 16153 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
CARD GUARD SCIENTIFIC SURVIVAL LTD510(k) NO: K110499(SPECIAL)
ATTN: CLAY ANSELMO PHONE NO : 303 223 4303
555 ZANG ST SUITE 100 SE DECISION MADE: 06-APR-11
LAKEWOOD CO 80228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES
US MEDICAL INNOVATIONS LLC 510(k) NO: K100669(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 512 327 9997
1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 06-APR-11
AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K100375(TRADITIONAL)
ATTN: PAMELA JURGA PHONE NO : 302 631 8891
PO BOX 6101 M/S 514 SE DECISION MADE: 06-APR-11
NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST
ALCOPRO, INC. 510(k) NO: K102225(TRADITIONAL)
ATTN: PERRY RUCKER PHONE NO : 310 415 7093
1560 E. EDINGER AVENUE, SUITE B SE DECISION MADE: 06-APR-11
SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAIRMAX LASERCOMB
LEXINGTON INTERNATIONAL, LLC 510(k) NO: K103368(TRADITIONAL)
ATTN: CASPER E ULDRIKS ESQ. PHONE NO : 202 518 6385
1400 SIXTEENTH STREET, NW SUITE 40SE DECISION MADE: 06-APR-11
WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO MBF
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K110494(SPECIAL)
ATTN: ELAINE CHANG PHONE NO : 847 304 7516
2501 NORTH BARRINGTON RD. SE DECISION MADE: 06-APR-11
HOFFMAN ESTATES IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ISA CO2, ISA AX+, ISA OR+
PHASEIN AB 510(k) NO: K103604(TRADITIONAL)
ATTN: DAVID WEISSBURG PHONE NO : 608 770 0223
4213 WINNEQUAH DR. SE DECISION MADE: 06-APR-11
MADISON WI 53716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRONTOSAN WOUND IRRIGATION SOLUTION
B. BRAUN MEDICAL, INC. 510(k) NO: K110744(TRADITIONAL)
ATTN: NANCY SKOCYPEC PHONE NO : 610 596 2796
901 MARCON BLVD. SE DECISION MADE: 06-APR-11
ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MULTIPLE BIOPSY SYSTEM
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K103326(TRADITIONAL)
ATTN: CARROLL L MARTIN PHONE NO : 440 639 4494
5976 HEISELY RD. SE DECISION MADE: 06-APR-11
MENTOR OH 44060 510(k) STATEMENT
DEVICE: NEWTOM 5G / NEWTOM 5G VERSION FP
QR S.R.L. 510(k) NO: K110260(SPECIAL)
ATTN: LORENZO BORTOLOTTI PHONE NO : 390 458 202727
VIA SILVESTRINI 20 SE DECISION MADE: 06-APR-11
VERONA, VR IT 37135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESUSCI FLOW; RESUSCI FLOW 104
ATOM MEDICAL CORPORATION 510(k) NO: K102542(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSTAGE DRIVE SE DECISION MADE: 06-APR-11
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VELA XL
STARMEDTEC GMBH 510(k) NO: K103654(TRADITIONAL)
ATTN: GREGOR WEIDEMANN PHONE NO : 498 151 268610
KREUZSTRASSE 22 SE DECISION MADE: 06-APR-11
STARNBERG GM 82319 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE DIGITAL UNDERARM THERMOMETER
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K103680(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456
55 NORTHERN BOULEVARD SUITE 200 SE DECISION MADE: 06-APR-11
GREAT NECK NY 10021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE BLLOD COLLECTION NEEDLE
WEIHAI HONGYU MEDICAL DEVICES CO.,510(k) NO: K103587(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
P.O. BOX 237-023 SE DECISION MADE: 06-APR-11
SHANGHAI CH 264200 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K110169(TRADITIONAL)
ATTN: KATHLEEN ANN DRAY-LYONS PHONE NO : 781 826 4551
500 GBC DRIVE PO BOX 6101 SE DECISION MADE: 07-APR-11
NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCULIF CAGE
COALIGN INNOVATIONS, INC. 510(k) NO: K110270(SPECIAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800
1331 H STREET NW 12TH FLOOR SE DECISION MADE: 07-APR-11
WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPERT C. DIFFICLE/EPI ASSAY
CEPHEID 510(k) NO: K110203(TRADITIONAL)
ATTN: RUSSEL K ENNS PHONE NO : 408 400 8230
904 CARIBBEAN DRIVE SE DECISION MADE: 07-APR-11
SUNNYVALE CA 94089 1189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOUNTAINEER OCT SPINAL SYSTEM
DEPUY SPINE, INC. 510(k) NO: K110353(SPECIAL)
ATTN: LUKE BULINO PHONE NO : 508 828 3267
325 PARAMOUNT DR. SE DECISION MADE: 07-APR-11
RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XVAC
SORIN GROUP ITALIA S.R.L. 510(k) NO: K110782(TRADITIONAL)
ATTN: BARRY SALL PHONE NO : 781 434 4742
195 WEST STREET SE DECISION MADE: 07-APR-11
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNAPSE 3D LIVER ANALYSIS
FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K110186(TRADITIONAL)
ATTN: KIMERLY A SHARP PHONE NO : 203 602 3665
419 WEST AVE. SE DECISION MADE: 07-APR-11
STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMS AIR-FLOW MASTER PIEZON
EMS ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K110173(TRADITIONAL)
ATTN: CYNTHIA J M. NOLTE, PH.D, RAPHONE NO : 919 859 4207
49 PLAIN ST. SE DECISION MADE: 07-APR-11
NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBITRANS MONITORING SETS AND ACCESSORIES
B. BRAUN MELSUNGEN AG 510(k) NO: K102033(ABBREVIATED)
ATTN: LISA GIAQUINTO PHONE NO : 610 596 2354
901 MARCON BLVD SE DECISION MADE: 07-APR-11
ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 4D SONO-SCAN 1.0
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K110595(TRADITIONAL)
ATTN: INGE SCHEIDT PHONE NO : 498 932 175515
EDISONSTRASSE 6 SE DECISION MADE: 07-APR-11
UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNI-VENT 731 SERIES MODEL EMV+ PORTABLE CRITICAL CARE VENTILATOR
IMPACT INSTRUMENTATION, INC. 510(k) NO: K103318(TRADITIONAL)
ATTN: SUSAN MCNEVIN PHONE NO : 973 882 1212
27 FAIRFIELD PL. P.O. BOX 508 SE DECISION MADE: 07-APR-11
WEST CALDWELL NJ 07006 0508 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UTA AND UHA
UTA 510(k) NO: K102467(TRADITIONAL)
ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934
3318 SUCCESFUL WAY SE DECISION MADE: 07-APR-11
DAYTON OH 45414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
RANDOX LABORATORIES, LTD. 510(k) NO: K092269(TRADITIONAL)
ATTN: P ARMSTRONG PHONE NO : 440 289 4422413
55 DIAMOND RD. SE DECISION MADE: 08-APR-11
CRUMLIN, COUNTY ANTRIM UK BT29 510(k) STATEMENT
DEVICE: INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000
INTUITIVE SURGICAL, INC. 510(k) NO: K101581(TRADITIONAL)
ATTN: BRANDON HANSEN PHONE NO : 408 523 2100
1266 KIFER ROAD SE DECISION MADE: 08-APR-11
SUNNYVALE CA 94086 5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDE III TONGUE SUSPENSION SYSTEM
SIESTA MEDICAL, INC. 510(k) NO: K110127(SPECIAL)
ATTN: MICHAEL KOLBER PHONE NO : 408 505 6626
101 CHURCH STREET SUITE 3 SE DECISION MADE: 08-APR-11
LOS GATOS CA 95030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGILIS ES STEERABLE INTRODUCER
ST. JUDE MEDICAL 510(k) NO: K103083(TRADITIONAL)
ATTN: LAURA MOEN-FTACEK PHONE NO : 651 756 2957
14901 DEVEAU PLACE SE DECISION MADE: 08-APR-11
MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAIRED HYDROGEL ELECTRODE
NEUROVISION MEDICAL PRODUCTS, INC.510(k) NO: K110138(SPECIAL)
ATTN: CHRISTINE VERGELY PHONE NO : 805 866 6999
2225 SPERRY AVE, SUITE 1000 SE DECISION MADE: 08-APR-11
VENTURA CA 93003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUITY WHISPER VIEW GUIDE WIRES
BOSTON SCIENTIFIC CORP. 510(k) NO: K110479(SPECIAL)
ATTN: KIRSTIN JOHNSTON PHONE NO : 651 582 5871
4100 HAMLINE AVE NORTH MS 9-330 SE DECISION MADE: 08-APR-11
ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET
ETHICON ENDO-SURGERY, LLC 510(k) NO: K103672(TRADITIONAL)
ATTN: DENNIS HAHN PHONE NO : 513 337 3134
4545 CREEK ROAD SE DECISION MADE: 08-APR-11
CINCINNATI OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE X-RAY SYSTEM
DIGIMED CORPORATION 510(k) NO: K103600(TRADITIONAL)
ATTN: KIM ANTOL PHONE NO : 847 419 0669
1607 N. BARCLAY AVE. SE DECISION MADE: 08-APR-11
BUFFALO GROVE IL 60089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESSURE RIGHT, SINGLE-USE, DISPOSABLE, PRESSURE-SENSITIVE EMETIC-MANAGEMENT WRIST STRIP
THERAPEUTICS 101, INC (DBA PRESSUR510(k) NO: K110563(TRADITIONAL)
ATTN: JULIE POWELL PHONE NO : 269 720 1329
611 WEST 5TH STREET THIRD FLOOR SE DECISION MADE: 08-APR-11
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTIMATE VIT ENHAMCER (UVE)
MEDICAL INSTRUMENT DEVELOPMENT LAB510(k) NO: K102222(TRADITIONAL)
ATTN: LINDA UPTON PHONE NO : 510 357 3952
557 MC CORMICK STREET SE DECISION MADE: 08-APR-11
SAN LEANDRO CA 94577 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K110667(TRADITIONAL)
ATTN: INGE SCHEIDT PHONE NO : 498 932 175515
EDISONSTRASSE 6 SE DECISION MADE: 08-APR-11
UNTERSCHLEISSHEIM GM D-85716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACAM 5 AUDIOMETER SYSTEM
ACOUSTICON GMBH 510(k) NO: K103298(TRADITIONAL)
ATTN: MAUREEN GARNER PHONE NO : 732 779 7422
1983 HAZELWOOD ROAD SE DECISION MADE: 08-APR-11
TOMS RIVER NJ 08754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY
MICROGENICS CORP. 510(k) NO: K101742(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142
46360 FREMONT BLVD SE DECISION MADE: 08-APR-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
MICROGENICS CORP. 510(k) NO: K101744(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142
46360 FREMONT BLVD SE DECISION MADE: 08-APR-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
MICROGENICS CORP. 510(k) NO: K101745(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142
46360 FREMONT BLVD SE DECISION MADE: 08-APR-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY
MICROGENICS CORP. 510(k) NO: K101746(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142
46360 FREMONT BLVD SE DECISION MADE: 08-APR-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XEROS DRY MOUTH PUMP
LORIN TECHNOLOGIES CORPORATION 510(k) NO: K110116(TRADITIONAL)
ATTN: AL TOMAN PHONE NO : 919 341 4128
436 WOODLAND DR SE DECISION MADE: 08-APR-11
SWANSBORO NC 28584 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18
ESAOTE S.P.A. 510(k) NO: K110802(SPECIAL)
ATTN: ALLISON SCOTT PHONE NO : 317 569 9500
11460 N MERIDIAN ST SUITE 150 SE DECISION MADE: 08-APR-11
CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICOLET WIRELESS EEG
CAREFUSION 209, INC. 510(k) NO: K103140(TRADITIONAL)
ATTN: ROBERT BURDGE PHONE NO : 608 829 8655
1850 Deming Way SE DECISION MADE: 08-APR-11
Middleton WI 53562 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HYDROFIX VASO SHIELD
MIMEDX GROUP, INC 510(k) NO: K101805(TRADITIONAL)
ATTN: SALLY THORSEN PHONE NO : 678 384 6720
811 LIVINGSTON COURT SE SUITE B SE DECISION MADE: 08-APR-11
MARIETTA GA 30067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS
MICROGENICS CORP. 510(k) NO: K101752(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142
46360 FREMONT BLVD SE DECISION MADE: 08-APR-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY
MICROGENICS CORP. 510(k) NO: K101753(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142
46360 FREMONT BLVD SE DECISION MADE: 08-APR-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY
MICROGENICS CORP. 510(k) NO: K101754(TRADITIONAL)
ATTN: LISA CHARTER PHONE NO : 510 979 5142
46360 FREMONT BLVD SE DECISION MADE: 08-APR-11
FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAKE 1 ADVANCED RIGID TRAY
KERR CORPORATION 510(k) NO: K110092(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602
1717 WEST COLLINS AVE. SE DECISION MADE: 08-APR-11
ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UF-760AG
FUKUDA DENSHI CO., LTD. 510(k) NO: K110920(TRADITIONAL)
ATTN: LORAN VAN NOY PHONE NO : 425 881 7737
17725 N.E. 65TH STREET BLDG C SE DECISION MADE: 08-APR-11
REDMOND WA 98052 4911 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMBIT TUNNELER
SUMMIT MEDICAL PRODUCTS, INC 510(k) NO: K110814(ABBREVIATED)
ATTN: MARKO V AMEN PHONE NO : 801 214 3464
2480 SOUTH MAIN STREET #212 SE DECISION MADE: 08-APR-11
SALT LAKE CITY UT 84118 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: APEX ER. YAG / IPL SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES LLC510(k) NO: K110304(TRADITIONAL)
ATTN: MARK ROHRER PHONE NO : 205 290 8251
105 CITATION COURT SE DECISION MADE: 08-APR-11
BIRMINGHAM AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCENARIA WHOLE-BODY X-RAY CT SYSTEM
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K101888(TRADITIONAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330 425 1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 08-APR-11
TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE BIPOLAR SYSTEM
ATRICURE, INC. 510(k) NO: K110117(TRADITIONAL)
ATTN: JAMES LUCKY, RAC PHONE NO : 513 755 5754
6217 CENTER PARK DRIVE SE DECISION MADE: 08-APR-11
WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT IN ZIRCONIA FOR OSSEOSPEED TX PROFILE IMPLANT
ASTRA TECH, INC. 510(k) NO: K103759(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847 560 4406
8944 TAMAROA TERR. SE DECISION MADE: 08-APR-11
SKOKIE IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEWPHEW ULTRABRAID II SUTURE
SMITH & NEWPHEW, INC 510(k) NO: K101377(TRADITIONAL)
ATTN: CHRISTINA FLORES PHONE NO : 508 261 3705
150 MINUTEMAND ROAD SE DECISION MADE: 08-APR-11
ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENOVO TEDDY GEL INFANT HEEL WARMER
DENOVO PRODUCTS LLC 510(k) NO: K103549(TRADITIONAL)
ATTN: DALE WALTERS PHONE NO : 239 245 7030
17051 Alico Commerce Court Unit 3 SE DECISION MADE: 08-APR-11
Fort Myers FL 33967 510(k) STATEMENT
DEVICE: LP CAGE
MEDYSSEY CO., LTD. 510(k) NO: K110067(TRADITIONAL)
ATTN: RICH JANSEN PHONE NO : 612 281 5505
13540 GUILD AVE SE DECISION MADE: 08-APR-11
APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATAMA SYSTEM
MONTERIS MEDICAL, INC. 510(k) NO: K110411(TRADITIONAL)
ATTN: JEFF WILSON PHONE NO : 204 272 2220
100 - 78 Innovation Drive SE DECISION MADE: 08-APR-11
Winnipeg CA R3T 6C2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-STAT DRY SILVER; D-STAT DRY CLEAR SILVER; D-STAT DRY WRAP SILVER; THROMBIX SILVER
VASCULAR SOLUTIONS, INC. 510(k) NO: K102212(TRADITIONAL)
ATTN: LISA GALLATIN PHONE NO : 763 656 4399
6464 SYCAMORE COURT SE DECISION MADE: 08-APR-11
MINNEAPOLIS MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
HOWMEDICA OSTEONICS CORP 510(k) NO: K101072(TRADITIONAL)
ATTN: KAREN ARIEMMA PHONE NO : 201 831 5718
325 CORPORATE DR. SE DECISION MADE: 11-APR-11
MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LATARJET CORTICAL SCREW SET
T.A.G. MEDICAL PRODUCTS CORPORATIO510(k) NO: K110763(SPECIAL)
ATTN: GEORGE J HATTUB PHONE NO : 508 479 6116
291 HILLSIDE AVENUE SE DECISION MADE: 11-APR-11
SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TAPER OXINIUM FEMORAL HEAD
SMITH & NEPHEW, INC. 510(k) NO: K110101(TRADITIONAL)
ATTN: SHEREEN MYERS PHONE NO : 901 396 2121
1450 EAST BROOKS RD. SE DECISION MADE: 11-APR-11
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMC-20 PORTABLE DENTAL CART MODEL AMC-20
ASEPTICO, INC. 510(k) NO: K101332(TRADITIONAL)
ATTN: CHERIE A TREGONING PHONE NO : 425 487 3157
8333 216TH ST., S.E. SE DECISION MADE: 11-APR-11
WOODINVILLE WA 98072 510(k) STATEMENT
DEVICE: DIMENSION VISTA LOCI CA 125 FLEX REAGENT CARTRIDGE,AND DIMENSIONS VISTA LOCI 6 CAL, MODEL#'S K6455, AND KC604
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K100321(TRADITIONAL)
ATTN: ROSE MARINELLI PHONE NO : 302 631 8805
MS 514, PO BOX 6101 SE DECISION MADE: 12-APR-11
NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO.CT CARDIAC FUNCTION
SIEMENS AG 510(k) NO: K110366(TRADITIONAL)
ATTN: RALF HOFFMANN PHONE NO :
51 VALLEY STREAM PKWY SE DECISION MADE: 12-APR-11
MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROPEP DELIVERY DEVICE
RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K103200(TRADITIONAL)
ATTN: JAMES M MEWBORNE PHONE NO : 803 252 1222
1140 FIRST STREET SOUTH SE DECISION MADE: 12-APR-11
COLUMBIA SC 29209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFUSION ADAPTER C100
CARMEL PHARMA AB. 510(k) NO: K110023(TRADITIONAL)
ATTN: KJELL ANDREASSON PHONE NO : 463 170 30400
AMINOGATAN 30 SE DECISION MADE: 12-APR-11
MOLNDAL SW S431 53 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050
CORELEADER BIOTECH CO., LTD. 510(k) NO: K102943(TRADITIONAL)
ATTN: IAN LI PHONE NO : 886 269 68880
19F NO. 100, SEC 1 SINTAI 5TH RD, SE DECISION MADE: 12-APR-11
TAIPEI, TAIWAN TW 22102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WALDO PATIENT MONITOR
WALDO HEALTH 510(k) NO: K110334(TRADITIONAL)
ATTN: ALAN R WEISS PHONE NO : 512 219 0302
4505 SPICEWOOD SPRINGS ROAD, SUITESE DECISION MADE: 12-APR-11
AUSTIN TX 78759 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDVOXEL HEARTPRO SOFTWARE APPLICATION
MEDVOXEL SYSTEMS INC 510(k) NO: K103565(TRADITIONAL)
ATTN: BONNIE SEWLOCHAN PHONE NO : 647 234 6643
2867 CROSSCURRENT DRIVE SE DECISION MADE: 12-APR-11
MISSISSAUGA CA L5N 6L1 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,
KAT IMPLANTS, LLC 510(k) NO: K101201(TRADITIONAL)
ATTN: VITALI BONDAR PHONE NO : 603 427 0084
15 RYE STREET SUITE 115 SE DECISION MADE: 13-APR-11
PORTSMOUTH NH 03801 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVA TPN BAG
VALMED S.R.L. 510(k) NO: K101412(TRADITIONAL)
ATTN: WALTER SVANOSIO PHONE NO : 390 342 052382
VIA PROVINCIALE 10 SE DECISION MADE: 13-APR-11
MAZZO DI VALTELLINA SO IT I 230510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPS450 MULTIPARAMETER SIMULATOR
FLUKE BIOMEDICAL 510(k) NO: K103336(TRADITIONAL)
ATTN: JOHN NELSON PHONE NO : 440 498 2579
6045 COCHRAN RD. SE DECISION MADE: 13-APR-11
SOLON OH 44139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONESTEP ADULT MULTI-FUNCTION ELECTRODE
ZOLL MEDICAL CORPORATION 510(k) NO: K110742(SPECIAL)
ATTN: ROBERT MORSE PHONE NO : 866 639 0060
525 NARRAGANSETT PARK DRIVE SE DECISION MADE: 13-APR-11
PAWTUCKET RI 02861 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K103795(TRADITIONAL)
ATTN: NANCY JOY PHONE NO : 732 661 2381
125 MAY STREET SE DECISION MADE: 13-APR-11
EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K103784(TRADITIONAL)
ATTN: NANCY JOY PHONE NO : 732 661 2381
125 MAY STREET SE DECISION MADE: 13-APR-11
EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITEX SPACE MAINTENANCE SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K110259(TRADITIONAL)
ATTN: KELLY DAVIDSON PHONE NO : 901 399 3035
1800 PYRAMID PLACE SE DECISION MADE: 13-APR-11
MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ODRC-DYNAMIC HIP SCREW SYSTEM
ORTHOPAEDIC DEVICE RESEARCH CENTER510(k) NO: K103015(TRADITIONAL)
ATTN: CHENG-KUNG CHENG PHONE NO : 886 228 267020
NO. 155, SEC. 2 LI-NUNG STREET SE DECISION MADE: 13-APR-11
TAIPEI TW 112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
IVOCLAR VIVADENT, INC. 510(k) NO: K103556(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010
175 PINEVIEW DR. SE DECISION MADE: 13-APR-11
AMHERST NY 14228 510(k) STATEMENT
DEVICE: NEWDEAL COMPRESSION PLATES
NEWDEAL SAS 510(k) NO: K093914(TRADITIONAL)
ATTN: STEPHEN BEIER PHONE NO : 609 936 5436
311 ENTERPRISE DR. SE DECISION MADE: 14-APR-11
PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE
3M COMPANY CORP 510(k) NO: K101468(TRADITIONAL)
ATTN: LINDA JOHNSON PHONE NO : 651 737 4376
3M CENTER, BLDG 275-5W-06 SE DECISION MADE: 14-APR-11
ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KELYNIAM CUSTOM SKULL IMPLANT (CSI)
KELYNIAM GLOBAL, INC 510(k) NO: K103582(TRADITIONAL)
ATTN: JAMES KETNER PHONE NO : 860 832 9331
200 MYRTLE STREET 2ND FLOOR SE DECISION MADE: 14-APR-11
NEW BRITAIN CT 06053 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
SHIJIAZHUANG GLORY PLASTIC CO., LT510(k) NO: K102085(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
# 209 BEI SI HUAN ZHONG ROAD RM 16SE DECISION MADE: 14-APR-11
BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICOR PD2I ANALYZER
VICOR TECHNOLOGIES, INC. 510(k) NO: K101867(TRADITIONAL)
ATTN: GLEN PARK PHONE NO : 212 681 2100
261 MADISON AVE. 24TH FLOOR SE DECISION MADE: 14-APR-11
NEW YORK NY 10016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
SMITH & NEPHEW, INC. 510(k) NO: K110240(SPECIAL)
ATTN: SHEREEN MYERS PHONE NO : 901 399 6325
1450 EAST BROOKS RD. SE DECISION MADE: 14-APR-11
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
NOVABONE PRODUCTS, LLC 510(k) NO: K110368(SPECIAL)
ATTN: DAVID M GAISSER PHONE NO : 386 462 7661
13631 PROGRESS BLVD SUITE 600 SE DECISION MADE: 14-APR-11
ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K110887(SPECIAL)
ATTN: ASHLEY PYLE PHONE NO : 508 683 4359
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 14-APR-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERCROSS 0.035" OTW PTA DILATATION CATHETER
EV3 INC 510(k) NO: K110319(SPECIAL)
ATTN: PAULA CORDERO PHONE NO : 763 398 7344
3033 CAMPUS DRIVE SE DECISION MADE: 14-APR-11
PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APNEA RISK EVALUATION SYSTEM (ARES)
ADVANCED BRAIN MONITORING INC. 510(k) NO: K110705(SPECIAL)
ATTN: ADRIENNE LENZ PHONE NO : 262 290 0023
2511 FOX RIVER CIRCLE SE DECISION MADE: 14-APR-11
WAUKESHA WI 53189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE ENDOMETRIAL SUCTION CURETTE
JIANGSU SUYUN MEDICAL MATERIALS CO510(k) NO: K102847(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
P.O. BOX 237-023 SE DECISION MADE: 14-APR-11
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTERTRAK LOGIC PSC TIBIAL INSERT
EXACTECH SARASOTA 510(k) NO: K110547(SPECIAL)
ATTN: PATRICK HUGHES PHONE NO : 352 377 1140
2320 NW 66TH COURT SE DECISION MADE: 14-APR-11
GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVERSE MEDICAL REPORT GUIDE CATHETER SYSTEM
REVERSE MEDICAL CORPORATION 510(k) NO: K102418(TRADITIONAL)
ATTN: AMY ESKINA PHONE NO : 949 215 0600
13900 ALTON PARKWAY SUITE 123 SE DECISION MADE: 15-APR-11
IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODEL MC-180MA MULTI-FREQUENCY BODY COMPOSITION ANALYZER
TANITA CORP. 510(k) NO: K100183(TRADITIONAL)
ATTN: TOSHISHIKO ISHIKAWA PHONE NO : 847 640 9241
2625 SOUTH CLEARBROOK DRIVE SE DECISION MADE: 15-APR-11
ARLINGTON HEIGHTS IL 60005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LANX SPINAL FIXATION SYSTEM
LANX, INC. 510(k) NO: K103091(SPECIAL)
ATTN: ANDREW LAMBORNE PHONE NO : 303 443 7500
390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 15-APR-11
BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER
ANGIOSCORE, INC. 510(k) NO: K110767(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794
555 THIRTEENTH STREET NW SE DECISION MADE: 15-APR-11
WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
INTERNATIONAL BIOMEDICAL, LTD. 510(k) NO: K103527(SPECIAL)
ATTN: AMY PIEPER PHONE NO : 512 873 0033
8508 CROSS PARK DR. SE DECISION MADE: 15-APR-11
AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX
INTERNATIONAL BIOMEDICAL, LTD. 510(k) NO: K103524(SPECIAL)
ATTN: AMY PIEPER PHONE NO : 512 873 0033
8508 CROSS PARK DR. SE DECISION MADE: 15-APR-11
AUSTIN TX 78754 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, CONVEX / LINEAR / PHASED ARRAY TRANSDUCER
SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K110841(SPECIAL)
ATTN: FLOWER CAI PHONE NO : 867 548 8250150
77 JINSHA ROAD SE DECISION MADE: 15-APR-11
SHANTOU, GUANGDONG CH 515041 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS
SPSMEDICAL SUPPLY CORP. 510(k) NO: K110152(TRADITIONAL)
ATTN: GARY J SOCOLA PHONE NO : 585 359 0130
6789 WEST HENRIETTA RD SE DECISION MADE: 15-APR-11
RUSH NY 14543 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS
CARDINAL HEALTH, INC. 510(k) NO: K110921(TRADITIONAL)
ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325
1430 WAUKEGAN ROAD SE DECISION MADE: 15-APR-11
MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ATMOS E 201 THORAX AND ATMOS S 201 THORAX
ATMOS INC. 510(k) NO: K103042(TRADITIONAL)
ATTN: MARCO SCHLEGEL PHONE NO : 610 740 1011
3717 HUCKLEBERRY ROAD SE DECISION MADE: 15-APR-11
ALLENTOWN PA 18104 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS; LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI
ZIMMER, INC. 510(k) NO: K103662(SPECIAL)
ATTN: REBECCA BROOKS PHONE NO : 574 371 8033
P.O. BOX 708 SE DECISION MADE: 15-APR-11
WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTISTE SOLUTION WITH SYS_VB50 UPDATE
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K103606(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925 602 8157
4040 NELSON AVE. SE DECISION MADE: 15-APR-11
CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K100344(TRADITIONAL)
ATTN: ROSE MARINELLI PHONE NO : 302 631 8805
MS 514, PO BOX 6101 SE DECISION MADE: 18-APR-11
NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INFILL INTERVERTEBRAL BODY FUSION DEVICE
PINNACLE SPINE GROUP, LLC 510(k) NO: K103729(TRADITIONAL)
ATTN: REBECCA K PINE PHONE NO : 760 809 5178
1601 ELM STREET, SUITE 300 SE DECISION MADE: 18-APR-11
DALLAS TX 75201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AOI CRANIAL HELMET
ADVANCED ORTHOPRO INC. 510(k) NO: K103362(TRADITIONAL)
ATTN: MOHAMAD MANSOORI PHONE NO : 317 924 4444
1820 N. ILLINOIS ST. SE DECISION MADE: 18-APR-11
INDIANAPOLIS IN 46202 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPICHAMBER VALVED HOLDING CHAMBER
TRUDELL MEDICAL INTL. 510(k) NO: K110136(TRADITIONAL)
ATTN: DARRYL FISHER PHONE NO : 519 455 7060
725 THIRD ST. SE DECISION MADE: 18-APR-11
LONDON, ONTARIO CA N5V 5G4 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS
GE MEDICAL SYSTEMS, LLC 510(k) NO: K093581(TRADITIONAL)
ATTN: TRACEY ORTIZ PHONE NO : 414 544 3026
3000 N GRANDVIEW BLVD. SE DECISION MADE: 19-APR-11
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WEXLER VASCULAR CLAMP SERIES
MICROSURGICAL LABORATORIES,INC.DBA510(k) NO: K110148(TRADITIONAL)
ATTN: LISA S JONES PHONE NO : 713 664 6775
540 COLLEGE STREET SE DECISION MADE: 19-APR-11
BELLAIRE TX 77401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONSERVE BIO FOAM SHELL
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K110029(TRADITIONAL)
ATTN: DANIELLE MUELLER PHONE NO : 901 290 5904
5677 AIRLINE ROAD SE DECISION MADE: 19-APR-11
ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING PIPETTE; PARTIAL ZONA DISSECTION (PZD) PIPETTE; ASSISTED HA
JIEYING LABORATORY INC. 510(k) NO: K102480(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949 262 0411
9722 AVE. SAUSALITO SE DECISION MADE: 19-APR-11
IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES
WEALTH ON (JIANGSU) CO., LTD 510(k) NO: K110219(TRADITIONAL)
ATTN: CHENGYU SHEN PHONE NO : 608 217 9358
5 CAREY STREET SE DECISION MADE: 19-APR-11
PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO YUECHUAN PLASTIC PRODUCTS CO.510(k) NO: K110338(TRADITIONAL)
ATTN: FRANK LIU PHONE NO : 909 548 4828
12390 EAST END AVENUE SE DECISION MADE: 19-APR-11
CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACELABS SMART DISCLOSURE SYSTEM
SPACELABS HEALTHCARE 510(k) NO: K110779(SPECIAL)
ATTN: THOMAS KROENKE PHONE NO : 303 956 4232
P.O. BOX 3018 SE DECISION MADE: 19-APR-11
NEDERLAND CO 80466 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVERON CENTRAL DISPLAY STATION (CDS)
EARLYSENSE LTD. 510(k) NO: K110521(SPECIAL)
ATTN: DALIA ARGAMAN PHONE NO : 972 375 22330X160
TZVI 12 SE DECISION MADE: 19-APR-11
RAMAT-GAN IS 52504 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NATUS SLEEPWORKS, MODEL 104017
EXCEL-TECH LTD. (XLTEK) 510(k) NO: K090277(TRADITIONAL)
ATTN: GOLDY SINGH PHONE NO : 905 829 5300
2568 BRISTOL CIR. SE DECISION MADE: 19-APR-11
OAKVILLE, ONTARIO CA L6H 5S1 510(k) STATEMENT
DEVICE: PARIETEX OPTIMIZED COMPOSTIE MESH
SOFRADIM PRODUCTION 510(k) NO: K110815(SPECIAL)
ATTN: JAMES MCMAHON PHONE NO : 781 839 1787
BIOSURGERY 15 CROSBY DRIVE SE DECISION MADE: 19-APR-11
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)
SOFRADIM PRODUCTION 510(k) NO: K110816(SPECIAL)
ATTN: JAMES MCMAHON PHONE NO : 781 839 1787
BIOSURGERY 15 CROSBY DRIVE SE DECISION MADE: 19-APR-11
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER
3M COMPANY-3M HEALTH CARE 510(k) NO: K103277(TRADITIONAL)
ATTN: SUZANNE LEUNG PHONE NO : 651 575 8052
3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 19-APR-11
ST. PAUL MN 55133 1006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIXEL CO2 LASER
BEIJING SYNTECH LASER CO., LTD. 510(k) NO: K110434(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 122 815850
P.O. BOX 237-023 SE DECISION MADE: 19-APR-11
SHANGHAI CH 200237 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FLEXIBLE CARDIAC COIL
LBDS HOLDING COMPANY 510(k) NO: K110487(TRADITIONAL)
ATTN: RICHARD BRYANT PHONE NO : 214 564 0146
6440 SKY POINTE DR SUITE 140 SE DECISION MADE: 19-APR-11
LAS VEGAS NV 89131 510(k) STATEMENT
DEVICE: BLUE SKY BIO DENTAL IMPLANT SYSTEM
BLUE SKY BIO, LLC 510(k) NO: K102034(TRADITIONAL)
ATTN: ALBERT ZICKMANN PHONE NO : 847 548 8499
888 E BELVIDERE RD. SUITE 212 SE DECISION MADE: 19-APR-11
GRAYSLAKE IL 60030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FDI GLUCOSE CONTROL SOLUTION FOR AVIVA
FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K110436(TRADITIONAL)
ATTN: KENT PRUETT PHONE NO : 830 372 1391
940 CROSSROADS BLVD. SE DECISION MADE: 20-APR-11
SEGUIN TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPUTED DENTAL RADIOGRAPHY
SCHICK TECHNOLOGIES, INC. 510(k) NO: K110768(SPECIAL)
ATTN: SCOTT DOYLE PHONE NO : 718 937 5765
30-30 47TH AVE. SE DECISION MADE: 20-APR-11
LONG ISLAND CITY NY 11101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELL-TISSUE CONVERTER (CTC) SYRINGE WITH NEEDLE
RONGSHAN LI 510(k) NO: K110112(TRADITIONAL)
ATTN: RONGSHAN LI PHONE NO : 414 241 1022
11 GEORGETOWN CT. SE DECISION MADE: 20-APR-11
BASKING RIDGE NJ 07920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UCP DRUG SCREENING TEST CUPS
UCP BIOSCIENCES, INC. 510(k) NO: K110515(SPECIAL)
ATTN: NANCY CHEN PHONE NO : 408 392 0064
1445 KOLL CIRCLE, STE. 111 SE DECISION MADE: 20-APR-11
SAN JOSE CA 95112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRE BALLOON DILATATION CATHETER
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K110833(SPECIAL)
ATTN: JANIS TARANTO PHONE NO : 508 683 4560
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 20-APR-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI TITANIUM BASE FOR CAD/CAM
THOMMEN MEDICAL, AG 510(k) NO: K102804(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235
11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 20-APR-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
UNILENS CORP., USA 510(k) NO: K110452(SPECIAL)
ATTN: ALAN J FRAZER PHONE NO : 727 544 2531
10431 72ND ST. NORTH SE DECISION MADE: 20-APR-11
LARGO FL 33777 510(k) STATEMENT
DEVICE: SATURN 8000-GS
NEW MEDICAL CO., LTD. 510(k) NO: K110210(TRADITIONAL)
ATTN: JUN-HSIUNG LIN PHONE NO : 909 244 6562
1460 ATTERBURY DR. SE DECISION MADE: 20-APR-11
WALNUT CA 91789 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMBIA.NET
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K110844(SPECIAL)
ATTN: ELAINE CHANG PHONE NO : 847 304 7516
2501 NORTH BARRINGTON RD. SE DECISION MADE: 20-APR-11
HOFFMAN ESTATES IL 60192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESUSCITATION UNIT 105
ATOM MEDICAL CORPORATION 510(k) NO: K103317(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155
24301 WOODSAGE DRIVE SE DECISION MADE: 20-APR-11
BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSTREAM NAVITUS SYSTEM; JETSTREAM G3 SF SYSTEM; JETSTREAM G3 SE SYSTEM; JETSTREAM G3 L SYSTEM
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K110626(SPECIAL)
ATTN: BRIAN CLEARY PHONE NO : 425 636 4079
10801 120TH AVENUE NE SE DECISION MADE: 20-APR-11
KIRKLAND WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOPIP PATIENT CIRCUIT WITH PEEP
NEOFORCE GROUP, INC. 510(k) NO: K103833(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215 672 6800
35 COMMERCE DR. SE DECISION MADE: 20-APR-11
IVYLAND PA 18974 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETCAM 3 OPTHALMIC IMAGING SYSTEM
CLARITY MEDICAL SYSTEMS 510(k) NO: K102859(TRADITIONAL)
ATTN: GARY A SEEGER PHONE NO : 925 463 7984
5775 WEST LAS POSITAS BLVD. SUITE SE DECISION MADE: 20-APR-11
PLEASANTON CA 94588 4084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOSCAF
TEXAS INNOVATIVE MEDICAL DEVICES (510(k) NO: K101827(TRADITIONAL)
ATTN: JERRY CHANG PHONE NO : 352 256 2707
4808 RESEARCH DRIVE SE DECISION MADE: 20-APR-11
SAN ANTONIO TX 78240 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SELECTRA CS LEAD INTRODUCER SYSTEM
BIOTRONIK, INC. 510(k) NO: K110461(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888 345 0374
6024 JEAN ROAD SE DECISION MADE: 20-APR-11
LAKE OSWEGO OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
MEDLINE INDUSTRIES, INC. 510(k) NO: K103602(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785
ONE MEDLINE PLACE SE DECISION MADE: 21-APR-11
MUNDELEIN IL 60060 4486 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
SYNTHES USA 510(k) NO: K110125(TRADITIONAL)
ATTN: CHRISTOPHER HACK, ESQ. PHONE NO : 610 719 6940
1301 GOSHEN PKWY SE DECISION MADE: 21-APR-11
WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
ORTHOGEM LIMITED 510(k) NO: K110787(SPECIAL)
ATTN: WE-JEN LO PHONE NO : 441 159 505721
BIOCITY, PENNYFOOT STREET SE DECISION MADE: 21-APR-11
NOTTINGHAM UK NG1 1GF 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELENA SYSTEM
ROYAL OAK MEDICAL DEVICES 510(k) NO: K110177(TRADITIONAL)
ATTN: MATTHEW KROLL PHONE NO : 248 628 2830
39533 WOODWARD AVENUE SE DECISION MADE: 21-APR-11
BLOOMFIELD HILLS MI 48304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IFUSE IMPLANT SYSTEM
SI-BONE, INC. 510(k) NO: K110838(SPECIAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611
1835 MARKET STREET 29TH FLOOR SE DECISION MADE: 21-APR-11
PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
INTRA-LOCK INTERNATIONAL, INC. 510(k) NO: K103194(ABBREVIATED)
ATTN: ANGELA BLACKWELL PHONE NO : 704 450 9934
6560 WEST ROGERS CIRCLE SE DECISION MADE: 21-APR-11
BOCA RATON FL 33487 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BODYFLOW P2CH
PHYSIOMED ELEKTROMEDIZIN AG 510(k) NO: K100862(TRADITIONAL)
ATTN: BIRGIT SCHMID PHONE NO : 499 126 258717
HUTWEIDE 10 SE DECISION MADE: 21-APR-11
SCHNAITTACH/LAIPERSDORF GM D-91510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURVE IMAGE
CURVE DENTAL, INC. 510(k) NO: K110139(TRADITIONAL)
ATTN: CAROLINE TONTINI PHONE NO : 512 327 9997
611 WEST 5TH STREET, THIRD FLOOR SE DECISION MADE: 21-APR-11
AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0
CEPHEID 510(k) NO: K103766(TRADITIONAL)
ATTN: KERRY J FLOM PHONE NO : 408 400 8460
904 CARIBBEAN DRIVE SE DECISION MADE: 21-APR-11
SUNNYVALE CA 94089 1189 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETPACK 2.0
PHILIPS MEDICAL SYSTEMS (CLEVELAND510(k) NO: K111024(TRADITIONAL)
ATTN: LORI R PETERSON PHONE NO : 408 468 3042
3860 NORTH 1ST STREET SE DECISION MADE: 21-APR-11
SAN JOSE CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EASYRA UREA NITROGEN AND CREATININE REAGENTS
MEDICA CORP. 510(k) NO: K110675(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781 541 7443
5 OAK PARK DRIVE SE DECISION MADE: 21-APR-11
BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION LIQUID OXYGEN SYSTEM
PRECISION MEDICAL, INC. 510(k) NO: K103324(TRADITIONAL)
ATTN: JAMES PARKER PHONE NO : 610 262 6090
300 HELD DRIVE SE DECISION MADE: 21-APR-11
NORTHAMPTON PA 18067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABEL
SYNTEX HEALTHCARE PRODUCTS CO., LT510(k) NO: K103770(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909 590 1611
3973 SCHAEFER AVE SE DECISION MADE: 21-APR-11
CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GSP NEONATAL THYROXINE (T4)
WALLAC OY, A SUBSIDIARY OF PERKINE510(k) NO: K103484(TRADITIONAL)
ATTN: SUSAN K HAMANN PHONE NO : 781 663 5872
940 WINTER STREET SE DECISION MADE: 22-APR-11
WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. MOBILITY SCOOTER HS515(3W)
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K110567(TRADITIONAL)
ATTN: SHEILA RAMERMAN PHONE NO : 541 683 3017
927 THRONE DRIVE SE DECISION MADE: 22-APR-11
EUGENE OR 97402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENX REVOLUTION
VENX LLC 510(k) NO: K110355(TRADITIONAL)
ATTN: IRA DUESLER PHONE NO : 315 868 5645
4700 S. OVERLAND DRIVE SE DECISION MADE: 22-APR-11
TUCSON' AZ 85714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. MOBILITY SCOOTER - MODEL HS 118
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K110395(TRADITIONAL)
ATTN: SHEILA RAMERMAN PHONE NO : 541 683 3017
927 THRONE DRIVE SE DECISION MADE: 22-APR-11
EUGENE OR 97402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REVISION PROTHESIS
SMITH & NEPHEW, INC. 510(k) NO: K110837(SPECIAL)
ATTN: MEGAN BEVILL PHONE NO : 901 399 5340
1450 EAST BROOKS RD. SE DECISION MADE: 22-APR-11
MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WINCO STRETCHAIR
WINCO MFG., LLC 510(k) NO: K110671(TRADITIONAL)
ATTN: JIM ANKOVIAK PHONE NO : 352 854 2929
5516 SW 1st Ln SE DECISION MADE: 22-APR-11
Ocala FL 34474 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUBBERCARE POWDER FREE LATEX EXAMINATION GLOVE, BLUE COLOR
RUBBERCARE PROTECTION PRODUCTS (M)510(k) NO: K102902(TRADITIONAL)
ATTN: LIM KWEE SHYAN PHONE NO : 606 677 2781
OFF JALAN SENAWANG EMPAT SENAWANG SE DECISION MADE: 22-APR-11
SEREMBAN, NEGERI SEMBILAN MY 70510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POSEY BED
J. T. POSEY CO. 510(k) NO: K103817(TRADITIONAL)
ATTN: ROBERT KELLEHER PHONE NO : 626 454 2109
5635 PECK RD. SE DECISION MADE: 22-APR-11
ARCADIA CA 91006 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVS ANCHOR-C CERVICAL CAGE SYSTEM
STRYKER SPINE 510(k) NO: K102606(TRADITIONAL)
ATTN: KIMBERLY LANE PHONE NO : 201 760 8215
2 PEARL COURT SE DECISION MADE: 22-APR-11
ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVADER MTHFR 1298
HOLOGIC, INC. 510(k) NO: K100496(TRADITIONAL)
ATTN: RANDALL J COVILL PHONE NO : 508 263 8853
250 CAMPUS DRIVE SE DECISION MADE: 25-APR-11
MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROTECTIVE RESTRAINT
MEDI-TECH INTL. CORP. 510(k) NO: K110377(TRADITIONAL)
ATTN: MARILYN GEIGER PHONE NO : 414 570 8880
26 COURT ST., SUITE 1301 SE DECISION MADE: 25-APR-11
BROOKLYN NY 11242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLCART B
B. BRAUN AVITUM AG 510(k) NO: K102194(TRADITIONAL)
ATTN: ANGELA CARAVELLA PHONE NO : 610 266 0500
901 MARCON BLVD. SE DECISION MADE: 25-APR-11
ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VAPRO PLUS INTERMITTENT CATHETER
HOLLISTER, INCORPORATED 510(k) NO: K110862(SPECIAL)
ATTN: CHRIS STUKEL PHONE NO : 847 918 3452
2000 HOLLISTER DRIVE SE DECISION MADE: 26-APR-11
;IBERTYVILLE IL 60048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAKONE SPHERICAL AND TORIC LENSES
ALDEN OPTICAL LABS., INC. 510(k) NO: K102557(TRADITIONAL)
ATTN: CHARLES H CREIGHTON PHONE NO : 716 937 9181
13295 BROADWAY SE DECISION MADE: 26-APR-11
ALDEN NY 14004 510(k) STATEMENT
DEVICE: AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
GE HEALTHCARE 510(k) NO: K110834(SPECIAL)
ATTN: HELEN PENG PHONE NO : 262 548 5091
3000 NORTH.GRANDVIEW BLVD. W1140 SE DECISION MADE: 26-APR-11
WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZEUS ELISA HSV GC-I IGG TEST SYSTEM
ZEUS SCIENTIFIC, INC. 510(k) NO: K103363(TRADITIONAL)
ATTN: EWA NADOLCZAK PHONE NO : 908 526 3744
200 EVANS WAY SE DECISION MADE: 26-APR-11
BRANCHBURG NJ 08876 510(k) STATEMENT
DEVICE: DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
EDAN INSTRUMENTS, INC. 510(k) NO: K110999(TRADITIONAL)
ATTN: RANDY JIANG PHONE NO : 867 552 6858736
4/F, NEW ENERGY BLDG., 2009 NANYOUSE DECISION MADE: 26-APR-11
NANSHAN, GUANGDONG CH 518054 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DISPOSABLE INSULIN SYRINGE
WENZHOU WUZHOU IMPORT & EXPORT CO.510(k) NO: K110421(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
P.O. BOX 237-023 SE DECISION MADE: 26-APR-11
BINGYI XIANG, ZHEJIANG CH 32500510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRESTODR 4143
CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K110849(SPECIAL)
ATTN: SHLOMI DINES PHONE NO : 972 485 66220
INDUSTRIAL PARK P.O.B. 111 SE DECISION MADE: 26-APR-11
YOQNEAM ILIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPELLA CONTROLLER WITH FLOW CONTROL
ABIOMED, INC. 510(k) NO: K110845(SPECIAL)
ATTN: ROBERT STEWART PHONE NO : 978 646 1567
22 CHERRY HILL DR. SE DECISION MADE: 27-APR-11
DANVERS MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIVERSAL DIGITAL INTERFACE (UDI) 1717
MERIDIAN MEDICAL SYSTEMS, LLC 510(k) NO: K103599(TRADITIONAL)
ATTN: ARIEL MARCIANO PHONE NO : 407 719 9853
325 HARRIS DRIVE SE DECISION MADE: 27-APR-11
AURORA OH 44202 510(k) STATEMENT
DEVICE: AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
TORNIER, INC. 510(k) NO: K110865(SPECIAL)
ATTN: BRAHIM HADRI PHONE NO : 978 232 9997
100 CUMMINGS CENTER, SUITE 444C SE DECISION MADE: 27-APR-11
BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIPLEX ER. YAG / ND: YAG SYSTEM
SANDSTONE MEDICAL TECHNOLOGIES, LL510(k) NO: K110502(TRADITIONAL)
ATTN: MARK ROHRER PHONE NO : 205 290 8251
105 CITATION COURT SE DECISION MADE: 27-APR-11
HOMEWOOD AL 35209 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
HEBEI TENGDA PLASTIC CO., LTD 510(k) NO: K102151(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG.1 JIANXIANG YUA NO.SE DECISION MADE: 27-APR-11
SHIJIAZHUANG CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FILMARRAY RP PANEL
IDAHO TECHNOLOGY, INC. 510(k) NO: K110764(TRADITIONAL)
ATTN: BETH LINGENFELTER PHONE NO : 801 736 6354
390 WAKARA WAY SE DECISION MADE: 27-APR-11
SALT LAKE CITY UT 84108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
SOLARC SYSTEMS INC. 510(k) NO: K103204(TRADITIONAL)
ATTN: BRUCE ELLIOTT PHONE NO : 705 739 3048
1515 SNOW VALLEY ROAD SE DECISION MADE: 27-APR-11
MINESING,ONTARIO CA L0L 1Y3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUBESCAN / BIOCON-700
MCUBE TECHNOLOGY CO., LTD. 510(k) NO: K111021(TRADITIONAL)
ATTN: SEUNGTAI KIM PHONE NO : 822 342 17780
803 SHINNAE-TECHNOTOWN 485 SANGBONSE DECISION MADE: 27-APR-11
CHUNGNANG-KU, SEOUL KS 131-220 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0
BECKMAN COULTER, INC. 510(k) NO: K103842(TRADITIONAL)
ATTN: MARINE BOYAJIAN PHONE NO : 714 961 6536
250 S. KRAEMER BOULEVARD MAIL STOPSE DECISION MADE: 27-APR-11
BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIGHTY DD INFUSION SET
MEDX-SET LTD 510(k) NO: K110282(TRADITIONAL)
ATTN: RAYMOND KELLY PHONE NO : 603 595 0095
56B SHAWDOW DR. SE DECISION MADE: 27-APR-11
HUDSON NH 03051 510(k) STATEMENT
DEVICE: TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
THUNDER TIGER CORP. 510(k) NO: K102517(TRADITIONAL)
ATTN: JO LEE PHONE NO : 886 423 591616
NO. 7, 6TH ROAD INDUSTRY PARK SE DECISION MADE: 27-APR-11
TAICHUNG TW 40755 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET
DIAZYME LABORATORIES 510(k) NO: K103557(TRADITIONAL)
ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762
12889 GREGG COURT SE DECISION MADE: 27-APR-11
POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCL TIGHTROPE
ARTHREX, INC. 510(k) NO: K110123(TRADITIONAL)
ATTN: COURTNEY SMITH PHONE NO : 239 643 5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 28-APR-11
NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
APEX BIOTECHNOLOGY CORP. 510(k) NO: K102481(SPECIAL)
ATTN: LISA LIU PHONE NO : 866 356 41952
NO. 7, LI-HSIN ROAD V, HSINCHU SCISE DECISION MADE: 28-APR-11
HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FEMVUE SALINE-AIR DEVICE
FEMASYS INC. 510(k) NO: K110288(TRADITIONAL)
ATTN: LISA PEACOCK PHONE NO : 770 500 3910
5000 RESEARCH COURT STE .100 SE DECISION MADE: 28-APR-11
SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
MICROVENTION, INC. 510(k) NO: K103758(SPECIAL)
ATTN: LARAINE PANGELINA PHONE NO : 714 247 8150
1311 VALENCIA AVE SE DECISION MADE: 28-APR-11
TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
HEBEI TENGDA PLASTIC CO., LTD 510(k) NO: K102152(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG.1 JIANXIANG YUA NO.SE DECISION MADE: 28-APR-11
SHIJIAZHUANG CH 100083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PEN NEEDLE
BECTON DICKINSON AND COMPANY (BD) 510(k) NO: K110105(SPECIAL)
ATTN: PASQUALE AMATO PHONE NO : 201 847 4513
1 BECTON DRIVE. MC372 SE DECISION MADE: 28-APR-11
FRANKLIN LAKES NJ 07417 1885 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONE DAY FLAT PACK
MENICON CO. LTD. 510(k) NO: K102895(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970 243 5490
806 KIMBALL AVENUE SE DECISION MADE: 28-APR-11
GRAND JUNCTION CO 81501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMARC FIDUCIAL MARKER
CARBON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K110772(TRADITIONAL)
ATTN: ANDREW J ADAMS PHONE NO : 651 653 8512
1290 HAMMOND RD. SE DECISION MADE: 28-APR-11
ST. PAUL MN 55110 5867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RENAISSANCE SYSTEM
MAZOR ROBOTICS LTD 510(k) NO: K110911(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
20 HATA'AS ST. SE DECISION MADE: 28-APR-11
KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA LASER SYSTEM
LUTRONIC CORPORATION 510(k) NO: K103455(SPECIAL)
ATTN: JHUNG WON VOJIR PHONE NO : 609 275 1565
51 EVERETT DRIVE, UNIT A-50 SE DECISION MADE: 28-APR-11
PRINCETON JUNCTION NJ 08550 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM)
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K103683(ABBREVIATED)
ATTN: GARO MIMARYAN PHONE NO : 914 524 3270
511 BENEDICT AVENUE SE DECISION MADE: 28-APR-11
TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
R & D SYSTEMS, INC. 510(k) NO: K101578(TRADITIONAL)
ATTN: NANCY RING PHONE NO : 612 656 4533
614 MCKINLEY PL., N.E. SE DECISION MADE: 28-APR-11
MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CUTTING EDGE SPINE INTERBODY FUSION DEVICE
CUTTING EDGE SPINE, LLC 510(k) NO: K102957(TRADITIONAL)
ATTN: JOHN KAPITAN PHONE NO : 704 843 7852
100 E. SOUTH MAIN STREET PO BOX 14SE DECISION MADE: 28-APR-11
MATTHEWS NC 28173 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AGACHAMBER SPACER
AGAPLASTIC IND. COM. LTDA. 510(k) NO: K101348(TRADITIONAL)
ATTN: MARIA F GRIFFIN PHONE NO : 704 843 1675
55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 29-APR-11
GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
CHANGDA PLASTIC PRODUCT CO., LTD 510(k) NO: K103196(TRADITIONAL)
ATTN: WANG LIN PHONE NO : 86 310 3096390
WANGZHUANG TOWN, LI COUNTY SE DECISION MADE: 29-APR-11
HANDAN CITY CH 056001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORTROSS BONE VOID FILLER
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K110561(SPECIAL)
ATTN: DAVID J COLLETTE PHONE NO : 858 792 1235
11234 EL CAMINO REAL SUITE 200 SE DECISION MADE: 29-APR-11
SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
DANA PRODUCTS, INC. 510(k) NO: K110253(TRADITIONAL)
ATTN: HARRY BALA PHONE NO : 847 455 2881
7 COREY DR. SE DECISION MADE: 29-APR-11
SOUTH BARRINGTON IL 60010 510(k) STATEMENT
DEVICE: KIMBERLY-CLARK LOW BARRIER, ASTM 2100 FACE MASKS
KIMBERLY-CLARK CORP. 510(k) NO: K110455(ABBREVIATED)
ATTN: ANN WATERHOUSE PHONE NO : 678 352 6719
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 29-APR-11
ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 240
TOTAL WITH SUMMARIES 226
TOTAL WITH STATEMENTS 14
