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Home » FDA releases November 510(k) clearances

FDA releases November 510(k) clearances

December 10, 2010 By MassDevice staff

FDA logo

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

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

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