Medical Devices
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November 2010 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD November 2010 DEVICE: RANDOX ETHANOL ASSAY RANDOX LABORATORIES, LTD. 510(k) NO: K092273(TRADITIONAL) ATTN: P. ARMSTRONG PHONE NO : 44 28 94422413 55 DIAMOND RD. SE DECISION MADE: 01-NOV-10 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS CA 125 II CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K102086(TRADITIONAL) ATTN: KELLY FRENCH PHONE NO : 317 521 2458 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 01-NOV-10 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCUCLEAR PRECISION BIPOLAR SORIN GROUP USA, INC. 510(k) NO: K102983(SPECIAL) ATTN: SCOTT LIGHT PHONE NO : 303 467 6313 14401 WEST 65TH WAY SE DECISION MADE: 01-NOV-10 ARVADA CO 80004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRANDIO SO VOCO GMBH 510(k) NO: K102351(SPECIAL) ATTN: MANFIELD T PLAUMANN PHONE NO : 494 721 719102 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 02-NOV-10 CUXHAVEN GM D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) GX CORPORATION SDN BHD 510(k) NO: K102074(TRADITIONAL) ATTN: CHO S FONG PHONE NO : 603 329 11600 LOT 6487A, BATU 5 3/4, SEMENTA JALSE DECISION MADE: 02-NOV-10 KLANG, SELANGOR DARUL EHSAN MY 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MUCHECK, VERSION 9.0 ONCOLOGY DATA SYSTEMS, INC. 510(k) NO: K102583(TRADITIONAL) ATTN: VINCENT RUMINER PHONE NO : 405 680 5222 1601 SW 89TH STREET BUILDING E-100SE DECISION MADE: 02-NOV-10 OKLAHOMA CITY OK 73159 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFLUX DIALYZER REPROCESSING SYSTEM NOVAFLUX TECHNOLOGIES 510(k) NO: K091360(TRADITIONAL) ATTN: MOHAMED E LABIB PHONE NO : 609 683 0215 1 WALL STREET SE DECISION MADE: 03-NOV-10 PRINCETON NJ 08540 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K100364(TRADITIONAL) ATTN: KAE MILLER PHONE NO : 303 222 6724 14143 DENVER WEST PARKWAY SUITE 40SE DECISION MADE: 03-NOV-10 LAKEWOOD CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IOLMASTER 500 CARL ZEISS MEDITEC AG 510(k) NO: K101182(TRADITIONAL) ATTN: JUDITH A BRIMACOMBE PHONE NO : 925 557 4616 5160 HACIENDA DRIVE SE DECISION MADE: 03-NOV-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISCOVERY NM 750B GE MEDICAL SYSTEMS ISRAEL, FUNCTIO510(k) NO: K102231(TRADITIONAL) ATTN: ELI WERNER PHONE NO : 972 485 63666 4 HAYOZMA STREET SE DECISION MADE: 03-NOV-10 TIRAT HACARMEL IS 30200 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K102930(SPECIAL) ATTN: LIU YI PHONE NO : 862 260 526161 NO 3 JIN PING STREET YA AN RD NANSE DECISION MADE: 03-NOV-10 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) MEMOMETAL TECHNOLOGIES 510(k) NO: K102072(TRADITIONAL) ATTN: GILLES AUDIC PHONE NO : 33 2 99055969 RUE BLAISE PASCAL CAMPUS DE KER LASE DECISION MADE: 03-NOV-10 BRUZ FR 35170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K102093(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 03-NOV-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRONTOSAN ANTIMICROBIAL WOUND GEL B. BRAUN MEDICAL, INC. 510(k) NO: K101882(TRADITIONAL) ATTN: MATTHEW J HOMA PHONE NO : 610 596 2558 901 MARCON BLVD. SE DECISION MADE: 03-NOV-10 ALLENTOWN PA 18109 9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K100917(SPECIAL) ATTN: COURIVAUD CHRISTELLE PHONE NO : 33 1 64621012 ACTIPOLE 25 4-6 BLD DE BEAUBOURG SE DECISION MADE: 03-NOV-10 MARNE LA VALLEE CEDEX 2 FR 7743510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING SOUTHWEST TECHNOLOGIES, INC. 510(k) NO: K102478(TRADITIONAL) ATTN: EDWARD I STOUT PHONE NO : 816 221 2442 1746 LEVEE RD. SE DECISION MADE: 03-NOV-10 KANSAS CITY MO 64116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB JIANGMEN CITY XINHUI BAISHENG MEDI510(k) NO: K102372(TRADITIONAL) ATTN: CHEN XI PHONE NO : 867 506 628113 BUILDING 1, NO.1, HUIMIN EAST RD HSE DECISION MADE: 03-NOV-10 JIANGMEN CITY, GUANGDONG CH 529510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SPIDER FLEX MONOPOLAR HOOK TRANSENTERIX, INC. 510(k) NO: K102646(SPECIAL) ATTN: BOBBI L HADERSBECK PHONE NO : 919 765 8400 635 DAVIS DRIVE SUITE 300 SE DECISION MADE: 03-NOV-10 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K102865(SPECIAL) ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 03-NOV-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR KAWASUMI LABORATORIES, INC. 510(k) NO: K102994(SPECIAL) ATTN: JACK PAVLO PHONE NO : 813 630 5554 4723 OAK FAIR BLVD SE DECISION MADE: 03-NOV-10 TAMPA FL 33610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RELIANCE SPINAL SCREW SYSTEM RELIANCE MEDICAL SYSTEMS 510(k) NO: K101112(SPECIAL) ATTN: BRET BARRY PHONE NO : 801 718 7467 545 SOUTH 500 WEST SUITE 100 SE DECISION MADE: 04-NOV-10 BOUNTIFUL UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRITY MODEL 1014284 ELEKTA LTD. 510(k) NO: K102200(TRADITIONAL) ATTN: ANDREW HEDGES PHONE NO : 441 293 654201 LINAC HOUSE FLEMING WAY, CRAWLEY SE DECISION MADE: 04-NOV-10 WEST SUSSEX UK RH10 9RR 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K102631(SPECIAL) ATTN: LIU YI PHONE NO : 86 22 60526161 NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 04-NOV-10 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING CARDINAL HEALTH, INC. 510(k) NO: K102500(TRADITIONAL) ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1500 WAUKEGAN ROAD SE DECISION MADE: 04-NOV-10 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VIVID I DIAGNOSTIC ULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. 510(k) NO: K102388(SPECIAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DR SE DECISION MADE: 04-NOV-10 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEPARIN DOSE RESPONSE CARTRIDGE MEDTRONIC INC. 510(k) NO: K102953(SPECIAL) ATTN: JEFFERY L KOLL PHONE NO : 763 514 9842 8200 CORAL SEA STREET NE SE DECISION MADE: 04-NOV-10 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) EXACTECH, INC. 510(k) NO: K102951(SPECIAL) ATTN: GRAHAM L CUTHBERT PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 04-NOV-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 SMITH & NEWPHEW, INC 510(k) NO: K102967(SPECIAL) ATTN: SHEREEN MYERS PHONE NO : 901 399 6325 1450 E. BROOKS ROAD SE DECISION MADE: 04-NOV-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 BYRNE MEDICAL INC. 510(k) NO: K102409(TRADITIONAL) ATTN: JOHN WILLIS PHONE NO : 936 521 4240 3150 POLLOK DR SE DECISION MADE: 04-NOV-10 CONROE TX 77303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFENET SYSTEM PHYSIO-CONTROL, INC. 510(k) NO: K102757(SPECIAL) ATTN: TERESA DAVIDSON PHONE NO : 425 867 4733 11811 WILLOWS ROAD NORTHEAST P.O. SE DECISION MADE: 05-NOV-10 REDMOND WA 98073 9706 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFE SPINE INTERSPINOUS FIXATION SYSTEM LIFE SPINE 510(k) NO: K100407(TRADITIONAL) ATTN: CHARLES P GILL PHONE NO : 847 884 6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 05-NOV-10 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPLORER 4D TREATMENT PLANNING SYSTEM AMERICAN RADIOSURGERY, INC. 510(k) NO: K101220(TRADITIONAL) ATTN: DAN OLIVER PHONE NO : 858 675 8200 16787 BERNARDO CENTER DR. SUITE A-SE DECISION MADE: 05-NOV-10 SAN DIEGO CA 92128 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARIETEX PLUG AND PATCH SOFRADIM PRODUCTION 510(k) NO: K101519(TRADITIONAL) ATTN: JAMES MCMAHON PHONE NO : 781 839 1787 15 CROSBY DRIVE SE DECISION MADE: 05-NOV-10 BEDFORD MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER BOSTON SCIENTIFIC CORPORATION 510(k) NO: K102527(TRADITIONAL) ATTN: DANIEL HOAR PHONE NO : 508 683 4156 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 05-NOV-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY ALPHATEC SPINE, INC. 510(k) NO: K102820(TRADITIONAL) ATTN: KARLA SCHAFFNER PHONE NO : 760 494 6739 5818 EL CAMINO REAL SE DECISION MADE: 05-NOV-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE EXACTECH, INC. 510(k) NO: K102975(SPECIAL) ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 05-NOV-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM GE MEDICAL SYSTEM ISRAEL LTD. 510(k) NO: K102393(SPECIAL) ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DR SE DECISION MADE: 05-NOV-10 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPACT TOUCH STS QUANTEL MEDICAL S.A. 510(k) NO: K102198(TRADITIONAL) ATTN: MIKE JOHNSON M.D. PHONE NO : 406 586 0131 601 HAGGERTY LANE SE DECISION MADE: 05-NOV-10 BOZEMAN MT 59715 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) PHILIPS ELECTRONICS UK LIMITED 510(k) NO: K101538(TRADITIONAL) ATTN: DIANA KORDA HEWITT PHONE NO : 004 417 87267069 PAMPISFORD ROAD SE DECISION MADE: 05-NOV-10 GREAT ABINGTON, CAMBRIDGE UK CB510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSKELETON TO TITAN SPINE, LLC 510(k) NO: K102067(TRADITIONAL) ATTN: RICH JANSEN PHONE NO : 952 431 5999 13540 GUILD AVE SE DECISION MADE: 05-NOV-10 APPLE VALLEY MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER MEDSHAPE SOLUTIONS 510(k) NO: K101808(TRADITIONAL) ATTN: JACK GRIFFS PHONE NO : 404 583 6889 1575 NORTHSIDE DR. SUITE 440 SE DECISION MADE: 08-NOV-10 ATLANTA GA 30318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE CURON SCIENTIFIC CO., LTD 510(k) NO: K102337(TRADITIONAL) ATTN: PETER WANG PHONE NO : 865 363 353322 NO. 6-2 XING'AN ROAD E EAST LINQU SE DECISION MADE: 08-NOV-10 WEIFANG CH 262600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 BYRNE MEDICAL INC. 510(k) NO: K102581(TRADITIONAL) ATTN: JOHN WILLIS PHONE NO : 936 521 4240 3150 POLLOK DR SE DECISION MADE: 08-NOV-10 CONROE TX 77303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 EXACTECH, INC. 510(k) NO: K102487(SPECIAL) ATTN: VLADISLAVA ZAITSEVA PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 08-NOV-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES TANGSHAN JITENG PLASTIC PRODUCTS C510(k) NO: K101943(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE SE DECISION MADE: 08-NOV-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAM STRUCTSURE BARS BIOMET 3I, INC. 510(k) NO: K101582(SPECIAL) ATTN: JOSE E CABRERA PHONE NO : 800 443 8166 4555 RIVERSIDE DR. SE DECISION MADE: 08-NOV-10 PALM BEACH GARDENS FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS BENLAN, INC. 510(k) NO: K102073(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 888 729 9674 P.O. BOX 4341 SE DECISION MADE: 08-NOV-10 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRANDIO SO HEAVY FLOW VOCO GMBH 510(k) NO: K102354(SPECIAL) ATTN: T GERKENSMEIER PHONE NO : 494 721 719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 08-NOV-10 CUXHAVEN GM D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX METABOLITE (EDDP) ASSAY RANDOX LABORATORIES, LTD. 510(k) NO: K092258(TRADITIONAL) ATTN: P. ARMSTRONG PHONE NO : 440 289 4422413 55 DIAMOND RD. SE DECISION MADE: 09-NOV-10 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) STATEMENT DEVICE: INTERFACE BIOSTRUCTURES 510(k) NO: K092541(TRADITIONAL) ATTN: DAVE BALDING PHONE NO : 949 412 0619 26552 TAMPICO PLACE SE DECISION MADE: 09-NOV-10 MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIRSCHNER WIRES, STEINMAN PINS EVERGREEN ORTHOPEDIC RESEARCH LAB 510(k) NO: K102215(TRADITIONAL) ATTN: WAYNE MORSE PHONE NO : 425 284 7262 11321 NE 120TH ST SE DECISION MADE: 09-NOV-10 KIRKLAND WA 98034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: OASYS SYSTEM STRYKER SPINE 510(k) NO: K101183(SPECIAL) ATTN: PAULINE SHAND PHONE NO : 201 760 8105 2 PEARL COURT SE DECISION MADE: 09-NOV-10 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DPL NUVE LED TECHNOLOGIES, LLC 510(k) NO: K101382(TRADITIONAL) ATTN: LEWIS WARD PHONE NO : 303 530 3279 4655 KIRKWOOD COURT SE DECISION MADE: 09-NOV-10 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMATRIX CO2 SYNERON MEDICAL LTD. 510(k) NO: K101321(TRADITIONAL) ATTN: AVI HIRSHNZON PHONE NO : 972 73 2442200 P.O. BOX 550 INDUSTRIAL ZONE SE DECISION MADE: 09-NOV-10 YOKNEAM ILLIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCKING COMPRESSION PLATE CHANGZHOU ORTHMED MEDICAL INSTRUME510(k) NO: K101400(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 86 21 64264467 ZHONGSHAN NO. 2 ROAD (SOUTH) SUITESE DECISION MADE: 09-NOV-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM AESCULAP, INC. 510(k) NO: K103003(SPECIAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 09-NOV-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K103041(SPECIAL) ATTN: JUDI SMITH PHONE NO : 410 592 2060 P.O. BOX 103 SE DECISION MADE: 09-NOV-10 BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM KIMBERLY-CLARK CORP. 510(k) NO: K102666(ABBREVIATED) ATTN: MARCIA JOHNSON PHONE NO : 770 587 8566 1400 HOLCOMB BRIDGE RD. BLDG 300, SE DECISION MADE: 09-NOV-10 ROSWELL GA 30076 2199 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM TORNIER, INC. 510(k) NO: K103007(SPECIAL) ATTN: BRAHIM HADRI PHONE NO : 978 232 9997 100 CUMMINGS CENTER SUITE 444C SE DECISION MADE: 09-NOV-10 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEQURE SNARE SYSTEM LIFETECH SCIENTIFIC (SHENZHEN) CO.510(k) NO: K102484(TRADITIONAL) ATTN: SHI XIAOLI PHONE NO : 867 558 6026250 LANGSHAN 2ND STREET NANSHAN DISTRISE DECISION MADE: 09-NOV-10 SHENZHENG, GUANGDONG CH 518057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K102344(TRADITIONAL) ATTN: LYNN HARMER PHONE NO : 425 487 7312 22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 09-NOV-10 BOTHELL WA 98041 8431 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRAUMATIC VASCULAR CLAMPS GEOMED MEDIZIN- TECHNIK GMBH & CO.510(k) NO: K102048(TRADITIONAL) ATTN: HARALD JUNG PHONE NO : 497 461 969236 UNTERER WINKEL 3 SE DECISION MADE: 09-NOV-10 WUMLINGEN GM 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTRONIC BLOOD PRESURE MONITOR SHENZHEN PANGO ELECTRONIC CO., LTD510(k) NO: K102988(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 09-NOV-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARE ZY5BA OXYGEN CONCENTRATOR FOSHAN CARE MEDICAL TECHNOLOGY CO.510(k) NO: K102245(TRADITIONAL) ATTN: KATHY GUO PHONE NO : 86 755 26715429 KEJIMAN 12 ROAD, HI-TEC IND PK HUASE DECISION MADE: 09-NOV-10 NANSHAN, SHENZHEN CH 518057 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BIOSIGN FLU A+B PRINCETON BIOMEDITECH CORP. 510(k) NO: K083746(TRADITIONAL) ATTN: KYUNG-AH KIM PHONE NO : 732 274 1000 4242 U.S. RT. 1 SE DECISION MADE: 10-NOV-10 MONMOUTH JUNCTION NJ 08852 1905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS EDAN INSTRUMENTS, INC. 510(k) NO: K100797(TRADITIONAL) ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD SUITE 200 SE DECISION MADE: 10-NOV-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIO STEADY EXTERNAL IMPLANT SYSTEM DIO CORPORATION 510(k) NO: K100100(TRADITIONAL) ATTN: TIMOTHY LEE PHONE NO : 213 365 2875 3540 WILSHIRE BLVD. SUITE 1104 SE DECISION MADE: 10-NOV-10 LOS ANGELES CA 90010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDGE CO2 LASER SYSTEM JM SYSTEM CO., LTD. 510(k) NO: K100590(TRADITIONAL) ATTN: SU-GUN LEE PHONE NO : 820 221 630158 410 DAERUNG TECHNO TOWN 8TH GASAN-SE DECISION MADE: 10-NOV-10 GEUMCHEN-GU, SEOUL, KS 153-77 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPROVIS IMAGING SYSTEM AMERICAN DENTAL PARTNERS, INC 510(k) NO: K101654(TRADITIONAL) ATTN: TIMOTHY RODENBERGER PHONE NO : 781 213 0255 401 EDGEWATER PLACE SUITE 430 SE DECISION MADE: 10-NOV-10 WAKEFIELD MA 01880 6225 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 BEST PUTRA GLOVES SDN BHD 510(k) NO: K101105(TRADITIONAL) ATTN: EFFENDI TENANG PHONE NO : 036 092 1042 MOHD TAIB, KAWASAN PERINDUSTRIAN SE DECISION MADE: 10-NOV-10 SG CHOH RAWANG, SELANGOR MY 480510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 BEST PUTRA GLOVES SDN BHD 510(k) NO: K101106(TRADITIONAL) ATTN: EFFENDI TENANG PHONE NO : 036 092 1042 MOHD TAIB, KAWASAN PERINDUSTRIAN SE DECISION MADE: 10-NOV-10 SG CHOH RAWANG, SELANGOR MY 480510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILK'N FLASH N GO HOME SKINOVATIONS LTD. 510(k) NO: K103184(TRADITIONAL) ATTN: AMIR WALDMAN PHONE NO : 972 547 404616 APOLO BUILDING POB 533 SE DECISION MADE: 10-NOV-10 YOKNEAM ILLIT IS 20692 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS ROSTAM LTD. 510(k) NO: K102445(TRADITIONAL) ATTN: ROBERT J STAAB PHONE NO : 860 434 5872 30 NECK ROAD SE DECISION MADE: 10-NOV-10 OLD LYME CT 06371 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 HUBDIC CO., LTD 510(k) NO: K101912(TRADITIONAL) ATTN: PETER CHUNG PHONE NO : 412 687 3976 300 ATWOOD SE DECISION MADE: 10-NOV-10 PITTSBURGH PA 15213 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VONFLEX HEAVY, VINFLEX LIGHT VERICOM CO., LTD. 510(k) NO: K103164(TRADITIONAL) ATTN: MYUNG-HWAN OH PHONE NO : 823 144 12881 #606,5TH DONGYOUNG VENTURESTEL 199SE DECISION MADE: 10-NOV-10 ANYANG-SI, GYEONGGI-DO KS 430-8510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE COVIDIEN LLC 510(k) NO: K103052(TRADITIONAL) ATTN: JENNIFER BRENNAN PHONE NO : 203 492 5346 60 MIDDLETOWN AVENUE SE DECISION MADE: 10-NOV-10 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCUS PEEK CF PUSH-IN SUTURE ANCHOR PARCUS MEDICAL, LLC 510(k) NO: K102162(TRADITIONAL) ATTN: BARTON BRACY PHONE NO : 920 746 2972 839 SOUTH NEENAH AVE. SE DECISION MADE: 10-NOV-10 STURGEON BAY WI 54235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS EXACTECH, INC. 510(k) NO: K103012(SPECIAL) ATTN: LINDY KNISELY PHONE NO : 352 377 1140 2320 N.W. 66TH CT. SE DECISION MADE: 10-NOV-10 GAINESVILLE FL 32653 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIVO NEBULIZER SYSTEM AEROGEN IRELAND, LTD. 510(k) NO: K102240(SPECIAL) ATTN: CAITRIONA CONNEELY PHONE NO : 353 915 02550 M&M QUALTECH, PARKMORE BUSINESS PASE DECISION MADE: 10-NOV-10 GALWAY EI 510(k) STATEMENT DEVICE: BLOOD SAMPLING SET ACACIA, INC. 510(k) NO: K103165(TRADITIONAL) ATTN: FERGIE FERGUSON PHONE NO : 714 257 0470 785 CHALLENGER STREET SE DECISION MADE: 10-NOV-10 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WELCH ALLYN 1500 PATIENT MONITOR SCHILLER AG 510(k) NO: K101619(TRADITIONAL) ATTN: SERKAN SEZER PHONE NO : 414 176 64242 ALTGASSE 68 SE DECISION MADE: 12-NOV-10 BAAR, ZG SZ 6341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSTELLATION VISION SYSTEM ALCON MANUFACTURING, LTD. 510(k) NO: K101285(TRADITIONAL) ATTN: MARTIN KAUFMAN PHONE NO : 949 753 6250 15800 ALTON PKWY. SE DECISION MADE: 12-NOV-10 IRVINE CA 92618 3818 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 ATRICURE, INC. 510(k) NO: K101174(TRADITIONAL) ATTN: JAMES LUCKY PHONE NO : 513 755 4130 6217 CENTER PARK DRIVE SE DECISION MADE: 12-NOV-10 WEST CHESTER OH 45069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) TANGSHAN HENGDA PLASTIC PRODUCTS C510(k) NO: K102558(TRADITIONAL) ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 #209 BEI SI HUAN ZHONG ROAD RM 160SE DECISION MADE: 12-NOV-10 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 VEGA TECHNOLOGIES, INC. 510(k) NO: K102626(TRADITIONAL) ATTN: JOSEPH LU PHONE NO : 886 225 416996 11F-13, 100 CHANG-CHUN RD. SE DECISION MADE: 12-NOV-10 TAIPEI TW 104 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCALP DURA RETRACTOR, MODEL KS00474 KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K093054(TRADITIONAL) ATTN: CRYSTAL DIZOL PHONE NO : 424 218 8381 2151 E. GRAND AVE. SE DECISION MADE: 15-NOV-10 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM LANX, INC. 510(k) NO: K100888(SPECIAL) ATTN: WILLIAM SANDUL PHONE NO : 303 443 7500 390 INTERLOCKEN CRESCENT SUITE 890SE DECISION MADE: 15-NOV-10 BROOMFIELD CO 80021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIPER F2 FACET FIXATION SYSTEM DEPUY SPINE, INC. 510(k) NO: K101762(SPECIAL) ATTN: FRANK JURCZAK PHONE NO : 508 828 3288 325 PARAMOUNT DR. SE DECISION MADE: 15-NOV-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR PARCUS MEDICAL, LLC 510(k) NO: K102326(TRADITIONAL) ATTN: BARION BRACY PHONE NO : 920 746 2972 839 SOUTH NEENAH AVE. SE DECISION MADE: 15-NOV-10 STURGEON BAY WI 54235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT CIANNA MEDICAL 510(k) NO: K103215(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949 360 0059 6 JOURNEY, SUITE 125 SE DECISION MADE: 15-NOV-10 ALISO VIEJO CA 92656 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM CHOICE SPINE, LP 510(k) NO: K102204(TRADITIONAL) ATTN: TODD HAWKINS PHONE NO : 865 246 3333 306 ERIN DRIVE SE DECISION MADE: 15-NOV-10 KNOXVILLE TN 37919 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTFE PORTABLE INTRODUCER GREATBATCH MEDICAL 510(k) NO: K102540(SPECIAL) ATTN: KRISTI FOX PHONE NO : 763 951 8181 2300 BERKSHIRE LANE NORTH SE DECISION MADE: 16-NOV-10 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPAROSCOPIC DISSECTOR APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K103282(TRADITIONAL) ATTN: FRANS VANDENBROEK PHONE NO : 949 713 8369 22872 AVENIDA EMPRESA SE DECISION MADE: 16-NOV-10 RANCHO SANTA MARGARITA CA 92688 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MINIATURIZE CHEST COMPRESSOR (MCC) RESUSCITATION INTERNATIONAL 510(k) NO: K102068(TRADITIONAL) ATTN: ROBYN SCOPIS PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 16-NOV-10 IRVINE CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES WUXI BINGFA GAINLITE GLOVES CP., L510(k) NO: K102171(TRADITIONAL) ATTN: CHENGYU SHEN PHONE NO : 608 217 9358 5 CAREY STREET SE DECISION MADE: 16-NOV-10 PENNINGTON NJ 08534 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) SHEN WEI (USA), INC. 510(k) NO: K101436(TRADITIONAL) ATTN: ABLERT LI PHONE NO : 510 429 8692 33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 17-NOV-10 UNION CITY CA 94587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 FUNDUS PHOTO, LLC 510(k) NO: K093071(TRADITIONAL) ATTN: DALE BRODSKY PHONE NO : 314 533 6000 3015 LOCUST STREET SE DECISION MADE: 17-NOV-10 SAINT LOUIS MO 63103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHITOGAUZE HEMCON MEDICAL TECHNOLOGIES, INC. 510(k) NO: K102546(SPECIAL) ATTN: KENDRA RATHKEY PHONE NO : 503 245 0459 10575 SW CASCADE AVENUE SUITE 130 SE DECISION MADE: 17-NOV-10 PORTLAND OR 97223 4363 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONCENTRIC BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC. 510(k) NO: K102657(TRADITIONAL) ATTN: KIRSTEN VALLEY PHONE NO : 650 938 2100 301 E. EVELYN AVE. SE DECISION MADE: 17-NOV-10 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWERPICC SV CATHETERS C.R. BARD, INC. 510(k) NO: K102159(TRADITIONAL) ATTN: JESSICA AGNELLO PHONE NO : 801 522 5651 605 NORTH 5600 WEST SE DECISION MADE: 17-NOV-10 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML BIOMERIEUX 510(k) NO: K102668(TRADITIONAL) ATTN: ASA KARLSSON PHONE NO : 334 788 75389 5 RUE DES AQUEDUCS SE DECISION MADE: 17-NOV-10 CRAPONNE FR 69290 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SA FLOWABLE ADHESIVE DMG USA, INC. 510(k) NO: K102603(ABBREVIATED) ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552 5 WHITCOMB AVE. SE DECISION MADE: 17-NOV-10 AYER MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BGM GALECTIN -3 BG MEDICINE, INC. 510(k) NO: K093758(TRADITIONAL) ATTN: CAROL ADILETTO PHONE NO : 781 405 8772 610N LINCOLN ST. SE DECISION MADE: 17-NOV-10 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K102807(SPECIAL) ATTN: CHRIS MCKEE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 17-NOV-10 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. 510(k) NO: K103100(SPECIAL) ATTN: EUGENE BANG PHONE NO : 508 977 3966 325 PARAMOUNT DR. SE DECISION MADE: 17-NOV-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG GREAT VISION PLASTIC 510(k) NO: K102097(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 17-NOV-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIODE LASER THERAPY SYSTEM CHINA DAHENG GROUP, INC. 510(k) NO: K102669(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 P.O. BOX 237-023 SE DECISION MADE: 17-NOV-10 SHANGHAI, CHINA CH 100085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM ACCURAY INCORPORATED 510(k) NO: K102650(TRADITIONAL) ATTN: ANNE SCHLAGENHAFT PHONE NO : 408 716 4628 1310 CHESAPEAKE TERRACE SE DECISION MADE: 17-NOV-10 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K102555(SPECIAL) ATTN: CHRIS MCKEE PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 17-NOV-10 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 MASIMO CORPORATION 510(k) NO: K101031(TRADITIONAL) ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7000 40 PARKER SE DECISION MADE: 18-NOV-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX METHADONE ASSAY RANDOX LABORATORIES, LTD. 510(k) NO: K092272(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 44 28 94422413 55 DIAMOND RD. SE DECISION MADE: 18-NOV-10 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING KAWASUMI LABORATORIES, INC. 510(k) NO: K100720(TRADITIONAL) ATTN: SUZAN ONEL PHONE NO : 202 778 9134 1601 K STREET, N.W. SE DECISION MADE: 18-NOV-10 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COULTER 4C-EX 300 CELL CONTROL BECKMAN COULTER, INC. 510(k) NO: K100607(TRADITIONAL) ATTN: LOURDES COBA PHONE NO : 305 380 4079 11800 SW 147TH AVE. SE DECISION MADE: 18-NOV-10 MIAMI FL 33196 2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-ROOT S-DENTI CO., LTD. 510(k) NO: K100450(TRADITIONAL) ATTN: TAE KYE NAM PHONE NO : 822 208 28828 505-14, GASAN-DONG GEUMCHEON-GU SE DECISION MADE: 18-NOV-10 SEONGNAM-CITY, SEOUL KS 153-803510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSOMETRICS SOFTWARE DPCOM AS 510(k) NO: K101133(TRADITIONAL) ATTN: CONSTANCE BUNDY PHONE NO : 763 574 1976 435 RICE CREEK TERRACE SE DECISION MADE: 18-NOV-10 FRIDLEY MN 55432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE TRUER MEDICAL INC. 510(k) NO: K101244(TRADITIONAL) ATTN: TIM TRUITT PHONE NO : 714 628 9785 1050 N BATAVIA STREET SE DECISION MADE: 18-NOV-10 ORANGE CA 92867 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES DRAGON HEART MEDICAL, INC. 510(k) NO: K101368(ABBREVIATED) ATTN: JINA YU PHONE NO : 630 833 6998 205 W GRAND AVE SUITE 105 SE DECISION MADE: 18-NOV-10 BENSENVILLE IL 510(k) STATEMENT DEVICE: HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P D.T. DAVIS ENTERPRISES LTD. T/A HO510(k) NO: K102236(TRADITIONAL) ATTN: SUSAN PAVELKO PHONE NO : 610 694 9600 513 SOUTH CLEWELL STREET SE DECISION MADE: 18-NOV-10 BETHLEHEM PA 18015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS PTH CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K103162(TRADITIONAL) ATTN: KELLY FRENCH PHONE NO : 317 521 3208 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 18-NOV-10 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRITICOOL PRO MTRE ADVANCED TECHNOLOGY LTD. 510(k) NO: K102112(TRADITIONAL) ATTN: IFAT OREN PHONE NO : 972 893 23333 4 HA-YARDEN ST. (P.O.BOX 102 REHOVSE DECISION MADE: 18-NOV-10 YAVNE IS 81228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROPLEX COIL SYSTEM- COSMOS MICROVENTION, INC. 510(k) NO: K102365(TRADITIONAL) ATTN: LARAINE PANGELINA PHONE NO : 714 247 8000 75 COLUMBIA SE DECISION MADE: 18-NOV-10 ALISO VIEJO CA 92656 1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAHADIR STERILIZATION TRAYS BAHADIR USA CORP. 510(k) NO: K102146(TRADITIONAL) ATTN: ISMAIL KILIC PHONE NO : 631 608 8522 275 WEST HOFFMAN AVENUE SE DECISION MADE: 18-NOV-10 LINDENHURST NY 11757 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K093891(ABBREVIATED) ATTN: PAUL BIGGINS PHONE NO : 714 730 5000 2441 MICHELLE DRIVE SE DECISION MADE: 18-NOV-10 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VELSCOPE VX LED DENTAL INC. 510(k) NO: K102083(TRADITIONAL) ATTN: DAVID MORGAN PHONE NO : 604 434 4614 235-5589 BYRNE ROAD SE DECISION MADE: 18-NOV-10 BURNABY , BC CA V5J 3J1 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOORVMS-PRES PRESSURE CUFF CONTROLLER MOOR INSTRUMENTS LTD. 510(k) NO: K102433(TRADITIONAL) ATTN: XIABING HUANG PHONE NO : 44 12 9735715 MILLWEY SE DECISION MADE: 18-NOV-10 AXMINSTER, DEVON UK EX135HU 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER REX MEDICAL 510(k) NO: K102043(SPECIAL) ATTN: SUSAN D GOLDSTEIN- FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 18-NOV-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIRELESS DR IMAGING OPTION-WDR1 GE MEDICAL SYSTEMS, LLC 510(k) NO: K102615(TRADITIONAL) ATTN: JOHN L SCHMIDT PHONE NO : 262 548 4964 3000 N GRANDVIEW BLVD. SE DECISION MADE: 18-NOV-10 WAUKESHA WI 53188 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 A PLUS MEDICAL 510(k) NO: K102377(TRADITIONAL) ATTN: THOMAS C LOESCHER PHONE NO : 760 930 4025 5431 AVENIDA ENCINAS SUITE G SE DECISION MADE: 18-NOV-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS AMERICAN DIAGNOSTIC CORP. 510(k) NO: K093495(TRADITIONAL) ATTN: MICHAEL FALCO PHONE NO : 631 273 9600 55 COMMERCE DR. SE DECISION MADE: 19-NOV-10 HAUPPAUGE NY 11788 510(k) STATEMENT DEVICE: 20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A) TOTOKU ELECTRIC CO., LTD 510(k) NO: K092728(TRADITIONAL) ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469 300 OYA , UEDA-SHI, SE DECISION MADE: 19-NOV-10 NAGANO-KEN JA 386-0192 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEON, OSTEON SINUS, OSTEON LIFTING GENOSS CO., LTD. 510(k) NO: K102015(SPECIAL) ATTN: EUNKYUNG SON PHONE NO : 714 895 7278 11075 KNOTT AVE., SUITE A SE DECISION MADE: 19-NOV-10 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H HINSON AND HALE MEDICAL TECHNOLOGI510(k) NO: K094016(TRADITIONAL) ATTN: JEFFREY O STULL PHONE NO : 512 288 8272 7809 ADELAIDE DRIVE SE DECISION MADE: 19-NOV-10 AUSTIN TX 78739 510(k) STATEMENT DEVICE: PENRITH ELETTRA ULTRASOUND SYSTEM PENRITH CORPORATION 510(k) NO: K100598(TRADITIONAL) ATTN: LAWRENCE ENGLE PHONE NO : 5170 CAMPUS DRIVE SUITE 2 SE DECISION MADE: 19-NOV-10 PLYMOUTH MEETING PA 19462 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SLEEP APP SLEEP MEDICINE NETWORK, INC. 510(k) NO: K100185(TRADITIONAL) ATTN: RICHARD MOORE PHONE NO : 503 255 1200 7931 NE HALSEY SUITE 305 SE DECISION MADE: 19-NOV-10 PORTLAND OR 97213 510(k) STATEMENT DEVICE: REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR HOYA PHOTONICS, INC. 510(k) NO: K103118(SPECIAL) ATTN: DONNA TEMPLEMAN PHONE NO : 925 846 0458 1105 SUNSET CREEK LANE SE DECISION MADE: 19-NOV-10 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS SGMP CO., LTD. 510(k) NO: K101822(TRADITIONAL) ATTN: JANNA P TUCKER PHONE NO : 775 342 2612 198 AVENUE DE LA D'EMERALD SE DECISION MADE: 19-NOV-10 SPARKS NV 89434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANOCERAM- BRIGHT DMP LTD 510(k) NO: K102257(TRADITIONAL) ATTN: DIMITRIS PRANTSIDIS PHONE NO : 003 022 99023041 KALYVION AVENUE MARKOPOULO INDUSTRSE DECISION MADE: 19-NOV-10 MARKOPOULO, ATTIKI GR 19003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARRIER N95 PARTICULATE RESPIRATOR MOLNLYCKE HEALTHCARE 510(k) NO: K102923(ABBREVIATED) ATTN: CAITLIN SENTER PHONE NO : 678 250 7928 5550 PEACHTREE PARKWAY SUITE 500 SE DECISION MADE: 19-NOV-10 NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOCO IONOFIL MOLAR AC QUICK VOCO GMBH 510(k) NO: K102612(TRADITIONAL) ATTN: T GERKENSMEIER PHONE NO : 49 472 1719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 19-NOV-10 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE ASAHI INTECC CO., LTD. 510(k) NO: K103057(SPECIAL) ATTN: YOSHI TERAI PHONE NO : 949 765 8252 2500 RED HILL SUITE 210 SE DECISION MADE: 19-NOV-10 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K102390(TRADITIONAL) ATTN: JESSICA R STENBERG PHONE NO : 425 951 1432 21919 30TH DRIVE SE. SE DECISION MADE: 19-NOV-10 BOTHELL WA 98021 3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 CARDIOQUIP LLP 510(k) NO: K102147(TRADITIONAL) ATTN: DOUGLAS PLATT PHONE NO : 979 691 0202 3827 OLD COLLEGE RD SE DECISION MADE: 19-NOV-10 BRYAN TX 77801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIVERSAL IRRIGATION SOLUTION HYBRID BYRNE MEDICAL, INC. 510(k) NO: K102855(TRADITIONAL) ATTN: JOHN WILLIS PHONE NO : 936 521 4240 3150 POLLOCK DR. SE DECISION MADE: 19-NOV-10 CONROE TX 77303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU STERIS CORPORATION 510(k) NO: K092745(TRADITIONAL) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 19-NOV-10 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUASHIELD SYSTEM PROTECTIVE PLUS EQUASHIELD MEDICAL LTD 510(k) NO: K101940(TRADITIONAL) ATTN: ELISSA BURG PHONE NO : 972 498 73737 TEFEN INDUSTRIAL PARK P.O. B 12 SE DECISION MADE: 19-NOV-10 IS 24959 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) BRIGHTWAY HOLDINGS SDN. BHD. 510(k) NO: K102880(TRADITIONAL) ATTN: NADARAJAN VENUGOPAL PHONE NO : 603 343 1007 LOT 1559, JALAN ISTIMEWA, BATU BELSE DECISION MADE: 19-NOV-10 KLANG, SELANGOR MY 42100 510(k) STATEMENT DEVICE: SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS STRYKER CORPORATION 510(k) NO: K103124(SPECIAL) ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DRIVE SE DECISION MADE: 19-NOV-10 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET MEDPRO SAFETY PRODUCTS, INC. 510(k) NO: K102010(ABBREVIATED) ATTN: H. CARL JENKINS PHONE NO : 847 234 7500 10 E. SCRANTON AVE SUITE 201 SE DECISION MADE: 19-NOV-10 LAKE BLUFF IL 60044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA OPTIA R APHERESIS SYSTEM CARIDIANBCT, INC. 510(k) NO: K103090(SPECIAL) ATTN: PATTI ARNDT PHONE NO : 303 231 4832 10811 W. COLLINS AVE SE DECISION MADE: 19-NOV-10 LAKEWOOD CO 80215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CSTS SCREW ORTHOPRO LLC 510(k) NO: K093055(TRADITIONAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 22-NOV-10 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEM 1E CHEMICAL INDICATOR STERIS CORPORATION 510(k) NO: K102217(TRADITIONAL) ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY ROAD SE DECISION MADE: 22-NOV-10 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) HENKE-SASS WOLF, GMBH. 510(k) NO: K101547(TRADITIONAL) ATTN: LYNETTE HOWARD PHONE NO : 908 788 4580 106 EAST 5TH AVENUE SE DECISION MADE: 22-NOV-10 MOUNT DORA FL 32757 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDERFREE BLACK NITRILE EXAMINATION GLOVES PT. MEDISAFE TECHNOLOGIES 510(k) NO: K102620(TRADITIONAL) ATTN: ANIL TANEJA PHONE NO : 62 61 30007134 JL.BATANG KUIS GG.TAMBAK REJO DESASE DECISION MADE: 22-NOV-10 MEDAN, NORTH SUMATERA ID 20362 510(k) STATEMENT DEVICE: SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 SMITH & NEPHEW, INC. 510(k) NO: K102122(TRADITIONAL) ATTN: CHRISTINA FLORES PHONE NO : 508 261 3705 130 FORBES BLVD. SE DECISION MADE: 22-NOV-10 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT HOWMEDICA OSTEONICS CORP 510(k) NO: K103104(SPECIAL) ATTN: AVITAL MERL-MARGULIES PHONE NO : 201 831 6365 325 CORPORATE DR. SE DECISION MADE: 22-NOV-10 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY COVIDIEN, FORMERLY US SURGICAL A D510(k) NO: K103263(SPECIAL) ATTN: FRANK GIANELLI PHONE NO : 203 492 5352 60 Middletown Ave SE DECISION MADE: 22-NOV-10 North Haven CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-3, MODEL M002-6A/2, LIGHTWALKER ST-N FOTONA D.D. 510(k) NO: K101817(TRADITIONAL) ATTN: STOJAN TROST PHONE NO : 386 150 09100 STEGNE 7, SE DECISION MADE: 22-NOV-10 LJUBLJANA SI 1210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS DENTIUM CO., LTD. 510(k) NO: K102308(SPECIAL) ATTN: EUNKYUNG SON PHONE NO : 714 895 7278 6761 KATELLA AVENUE SE DECISION MADE: 22-NOV-10 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES ZIBO YINGBO MEDICAL PRODUCTS, INC.510(k) NO: K102444(TRADITIONAL) ATTN: FRANK LIU PHONE NO : 909 548 4828 12390 EAST END AVE. SE DECISION MADE: 22-NOV-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDRANGE ELECTROSURGICAL GENERATOR MEDRANGE CORPORATION 510(k) NO: K102114(TRADITIONAL) ATTN: HARRY WOODS PHONE NO : 714 784 5204 480 APOLLO STREET, SUITE D BREA, SE DECISION MADE: 22-NOV-10 LOS ANGELES CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIDI DENTAL IMPLANT SYSTEM AIDI BIOMEDICAL LLC 510(k) NO: K101755(TRADITIONAL) ATTN: WILLIAM Y.S. HUNG PHONE NO : 951 288 8819 34859 FREDERICK ST #105 SE DECISION MADE: 22-NOV-10 WILDOMAR CA 92595 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRINITY ACETABULAR SYSTEM CORIN U.S.A. 510(k) NO: K093472(TRADITIONAL) ATTN: ASHLEA BOWEN PHONE NO : 813 977 4469 10500 UNIVERSITY CENTER DR., SUITESE DECISION MADE: 23-NOV-10 TAMPA FL 33612 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCKING BONE SCREW MODEL HCQ04, HCZ04 CHANGZHOU ORTHMAR MEDICAL INSTRUME510(k) NO: K100721(TRADITIONAL) ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 5D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 23-NOV-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCANVIEW HER2/NEU FISH SYSTEM APPLIED SPECTRAL IMAGING, LTD. 510(k) NO: K101291(TRADITIONAL) ATTN: DAN LAOR PHONE NO : 972 4 8246632 6 SIRENI SE DECISION MADE: 23-NOV-10 HAIFA IS 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOGEL ORTHOPRO INDICATOR UNDERGLOVE MOLNLYCKE HEALTH CARE USA 510(k) NO: K101163(TRADITIONAL) ATTN: ANGELA BUNN PHONE NO : 678 250 7930 5550 PEACHTREE PKWY., STE. 500 SE DECISION MADE: 23-NOV-10 NORCROSS GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 ARK DIAGNOSTICS,INC 510(k) NO: K101574(TRADITIONAL) ATTN: JOHNNY VALDEZ PHONE NO : 408 747 0706 1190 BORDEAUX DRIVE SE DECISION MADE: 23-NOV-10 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLICKFINE PEN NEEDLE YPSOMED AG 510(k) NO: K102108(SPECIAL) ATTN: MANFRED MADER PHONE NO : 41 344 244111 BRUNNMATTSTRASSE 6 SE DECISION MADE: 23-NOV-10 BURGDORF SZ CH-3401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EASYSUITE SURGICAL LIGHT CONTROL (ESLC) IMAGE STREAM MEDICAL, INC. 510(k) NO: K102791(SPECIAL) ATTN: BETH CYR PHONE NO : 978 486 8494 ONE MONARCH DR. SE DECISION MADE: 23-NOV-10 LITTLETON MA 01460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRA ELECTRODE TUNNELING NEEDLE INTEGRA LIFESCIENCES CORPORATION 510(k) NO: K102802(TRADITIONAL) ATTN: DEREK CAO PHONE NO : 609 275 2794 311 ENTERPRISE DR. SE DECISION MADE: 23-NOV-10 PLAINSBORO NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI EXPRESS INFINIUM MEDICAL 510(k) NO: K103268(SPECIAL) ATTN: JOHN OBRIEN PHONE NO : 813 645 2855 962 ALLEGRO LN. SE DECISION MADE: 23-NOV-10 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATCHASSIST LARGE POLYTOUCH MEDICAL LTD 510(k) NO: K103269(SPECIAL) ATTN: LEO BASTA PHONE NO : 617 834 9866 755 WESTMINSTER STREET UNIT 120 SE DECISION MADE: 23-NOV-10 PROVIDENCE RI 02903 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PVS MODEL 1.0 MEDCOM GMBH 510(k) NO: K102237(TRADITIONAL) ATTN: STEFAN WALTER PHONE NO : 496 151 9514717 RUNDETURMSTR. 12 SE DECISION MADE: 23-NOV-10 DARMSTADT, HESSEN GM 64283 510(k) STATEMENT DEVICE: DMP SINGLE BONDING DMP LTD 510(k) NO: K102254(TRADITIONAL) ATTN: DIMITRIS PRANTSIDIS PHONE NO : 003 022 99023041 KALYVION AVENUE MARKOPOULO INDUSTRSE DECISION MADE: 23-NOV-10 MARKOPOULO, ATTIKI GR 19003 510(k) STATEMENT DEVICE: DMP ETCHING GEL DMP LTD 510(k) NO: K102255(TRADITIONAL) ATTN: DIMITRIS PRANTSIDIS PHONE NO : 003 022 99023041 KALYVION AVENUE MARKOPOULO INDUSTRSE DECISION MADE: 23-NOV-10 MARKOPOULO, ATTIKI GR 19003 510(k) STATEMENT DEVICE: PREASSEMBLED SURGICAL WASH SET SORIN GROUP ITALIA S.R.L. 510(k) NO: K103202(SPECIAL) ATTN: BARRY SALL PHONE NO : 781 434 4742 195 WEST STREET SE DECISION MADE: 23-NOV-10 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY RECLAIM REVISION HIP SYSTEM DEPUY (IRELAND) 510(k) NO: K102080(TRADITIONAL) ATTN: RHONDA MYER PHONE NO : 574 371 4927 700 ORTHOPAEDIC DRIVE SE DECISION MADE: 23-NOV-10 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCULMAING RADIOLOGY INFORMATION SYSTEMS, INC510(k) NO: K102849(TRADITIONAL) ATTN: E.J. SMITH PHONE NO : 410 451 0639 1468 HARWELL AVE. SE DECISION MADE: 23-NOV-10 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K102429(TRADITIONAL) ATTN: MEGAN MCCAGH PHONE NO : 901 290 5909 5677 AIRLINE RD. SE DECISION MADE: 23-NOV-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K102904(ABBREVIATED) ATTN: CLARE SANTULLI PHONE NO : 914 524 2701 511 BENEDICT AVENUE SE DECISION MADE: 23-NOV-10 TARRYTOWN NY 10591 5097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GS 3000 EMSI 510(k) NO: K102202(TRADITIONAL) ATTN: CHERITA JAMES PHONE NO : 703 562 9800 901 KING STREET SUITE 200 SE DECISION MADE: 23-NOV-10 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIBER FORCE SYNCA MARKETING, INC. 510(k) NO: K102207(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 713 467 2607 12946 KIMBERLEY LN SE DECISION MADE: 23-NOV-10 HOUSTON TX 77079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM EMERGE MEDICAL 510(k) NO: K102343(TRADITIONAL) ATTN: CURTIS RAYMOND PHONE NO : 203 922 0105 80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 23-NOV-10 SHELTON CO 80202 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE CONMED LINVATEC 510(k) NO: K102339(TRADITIONAL) ATTN: JAN FLEGEAU PHONE NO : 727 399 5433 11311 CONCEPT BOULEVARD SE DECISION MADE: 23-NOV-10 LARGO FL 33773 4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROW ANATOMICAL SHOULDER SYSTEM FOURNITURES HOSPITALIERES INDUSTRI510(k) NO: K093599(TRADITIONAL) ATTN: PATRICIA DONNARD PHONE NO : 332 985 56895 ZI DE KERNEVEZ-6 RUE NOBEL SE DECISION MADE: 24-NOV-10 QUIMPER FR 29000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLASMALUXLS DAAVLIN DISTRIBUTING CO. 510(k) NO: K100628(TRADITIONAL) ATTN: MICHELE THIEL PHONE NO : 419 636 6304 205 WEST BEMENT ST. SE DECISION MADE: 24-NOV-10 BRYAN OH 43506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAX-IF1000 BIO PROTECH, INC. 510(k) NO: K100246(TRADITIONAL) ATTN: JUDY BURTON PHONE NO : 972 243 5105 3010 LBJ FRWY. 12TH FLOOR SE DECISION MADE: 24-NOV-10 DALLAS TX 75234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM CONMED CORP. 510(k) NO: K101534(TRADITIONAL) ATTN: SHAWN REIDEL PHONE NO : 303 268 9495 14603 E. FREMONT AVE. SE DECISION MADE: 24-NOV-10 CENTENNIAL CO 80112 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AXLE INTERSPINOUS FUSION SYSTEM X-SPINE SYSTEMS, INC. 510(k) NO: K101471(TRADITIONAL) ATTN: DAVID KIRSCHMAN PHONE NO : 937 847 8400 452 ALEXANDERSVILLE RD. SE DECISION MADE: 24-NOV-10 MIAMISBURG OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AERODR SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K102349(TRADITIONAL) ATTN: RUSSELL MUNVES PHONE NO : 212 497 8208 140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 24-NOV-10 NEW YORK NY 10017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K102690(SPECIAL) ATTN: LIU YI PHONE NO : 862 260 5261618060 NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 24-NOV-10 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLEXA FLU A/B & RSV FOCUS DIAGNOSTICS, INC. 510(k) NO: K102170(TRADITIONAL) ATTN: TARA VIVIANI PHONE NO : 714 822 2115 11331 VALLEY VIEW ST SE DECISION MADE: 24-NOV-10 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-DEC 200 DENTAL SYSTEM A-DEC, INC. 510(k) NO: K102234(TRADITIONAL) ATTN: THOMAS H LOUISELL PHONE NO : 503 538 9471 2601 CRESTVIEW DR. SE DECISION MADE: 24-NOV-10 NEWBERG OR 97132 9257 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HTO PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, LLC 510(k) NO: K102505(SPECIAL) ATTN: KATHY A RACOSKY PHONE NO : 610 984 9291 3773 CORPORATE PARKWAY SE DECISION MADE: 24-NOV-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K100199(TRADITIONAL) ATTN: TERI JUCKETT PHONE NO : 518 798 1215 603 QUEENSBURY AVE. SE DECISION MADE: 26-NOV-10 QUEENSBURY NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX GREATBATCH MEDICAL 510(k) NO: K101784(TRADITIONAL) ATTN: KRISTI FOX PHONE NO : 763 951 8181 2300 BERKSHIRE LANE NORTH SE DECISION MADE: 26-NOV-10 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE FOOTPRINT MEDICAL INC. 510(k) NO: K102548(TRADITIONAL) ATTN: CLYDE N BAKER PHONE NO : 210 226 2600 1203 CAMDEN STREET SE DECISION MADE: 26-NOV-10 SAN ANTONIO TX 78215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUINOX CO2 LASER SYSTEM ECLIPSEMED GLOBAL, INC 510(k) NO: K100487(TRADITIONAL) ATTN: CONNIE HOY PHONE NO : 972 380 2911 16850 DALLAS PARKWAY SE DECISION MADE: 29-NOV-10 DALLAS TX 75248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENUS FREEZE SYSTEM VENUS CONCEPT LTD 510(k) NO: K100586(TRADITIONAL) ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST SE DECISION MADE: 29-NOV-10 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG PERUSAHAAN GETAH ASAS SDN BHD 510(k) NO: K102790(TRADITIONAL) ATTN: S F CHO PHONE NO : 603 329 12657 LOT 1365, BATU 17 JALAN SEMBILANG SE DECISION MADE: 29-NOV-10 KLANG, SELANGOR MY 45800 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL FLAT PANEL X-RAY DETECTOR VATECH CO., LTD. 510(k) NO: K101590(TRADITIONAL) ATTN: DAVE KIM PHONE NO : 832 623 2099 333 MEADOWLANDS PARKWAY #303 SE DECISION MADE: 29-NOV-10 SECAUCUS NJ 07094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES SEQUAL TECHNOLOGIES CO., LTD 510(k) NO: K100920(ABBREVIATED) ATTN: CEARO HUANG PHONE NO : 886 227 00273729 6F-7, NO.136, SEC. 3 REN-AI RD SE DECISION MADE: 29-NOV-10 TAIPEI TW 10657 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVANCE D-DIMER, MODEL OPBP09 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K093626(TRADITIONAL) ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781 826 4551 500 GBC DRIVE M/S 514 PO BOX 6101 SE DECISION MADE: 29-NOV-10 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ICESENCE 3 ICECURE MEDICAL LTD. 510(k) NO: K102360(TRADITIONAL) ATTN: ELISABETH SADKA PHONE NO : 972 462 30333 HAESHEL 7 SE DECISION MADE: 29-NOV-10 CAESARIA IS 38900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA ADVANCED SURGICAL CONCEPTS 510(k) NO: K101794(SPECIAL) ATTN: ROSINA ROBINSON PHONE NO : 508 643 0434 49 PLAIN ST. SE DECISION MADE: 29-NOV-10 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS DIAZYME LABORATORIES 510(k) NO: K102638(ABBREVIATED) ATTN: ABHIJIT DATTA PHONE NO : 858 455 4762 12889 GREGG COURT SE DECISION MADE: 30-NOV-10 POWAY CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAXX(R) XD SYSTEM SPINE WAVE, INC. 510(k) NO: K102682(SPECIAL) ATTN: ROAIADA RIZKALLAH PHONE NO : 203 944 9494 3 ENTERPRISE DR SUITE 210 SE DECISION MADE: 30-NOV-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 206 TOTAL WITH SUMMARIES 193 TOTAL WITH STATEMENTS 13
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