Medical Devices
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October 2010 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD October 2010 DEVICE: PERFADEX AND PERFADEX WITH THAM XVIVO PERFUSION AB 510(k) NO: K091989(SPECIAL)
ATTN: KJELL KJORK PHONE NO : 46 31 7218077 BOX 9080 SE DECISION MADE: 01-OCT-10 GOTEBORG SW SE-40092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM DIFUSION TECHNOLOGIES 510(k) NO: K100042(TRADITIONAL)
ATTN: JAMI HAFIZ PHONE NO : 612 804 4180 701 BRAZOS STREET SUITE 500 SE DECISION MADE: 01-OCT-10 AUSTIN TX 78701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM ZEUS SCIENTIFIC, INC. (ZEUS) 510(k) NO: K093837(TRADITIONAL) ATTN: EWA NADOLCZAK PHONE NO : 347 731 0402 P.O. BOX 38 SE DECISION MADE: 01-OCT-10 RARITAN NJ 08869 510(k) STATEMENT DEVICE: MAGNETOM AERA; MAGNETOM SKYRA SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K101347(TRADITIONAL)
ATTN: KIM RENDON PHONE NO : 610 448 1773 53 VALLEY STREAM PARKWAY SE DECISION MADE: 01-OCT-10 MALVERN PA 19533 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA HEIDELBERG ENGINEERING 510(k) NO: K101223(TRADITIONAL)
ATTN: DIANE MANDELL-HORWITZ PHONE NO : 703 307 2921 1220 NINETEENTH ST, NW SUITE 300 SE DECISION MADE: 01-OCT-10 WASHINGTON DC 20036 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM 3M COMPANY 510(k) NO: K101528(TRADITIONAL)
ATTN: SUZANNE LEUNG PHONE NO : 651 575 8052 3M CENTER, BLDG. 275-5W-06 SE DECISION MADE: 01-OCT-10 ST. PAUL MN 55144 1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROMED PD-8K INSULATION DEFECT DETECTOR MCGAN TECHNOLOGY, LLC 510(k) NO: K101606(TRADITIONAL)
ATTN: JACK GANIS PHONE NO : 508 876 1070 410 RIDGE ROAD SE DECISION MADE: 01-OCT-10 MIDDLETOWN CT 06457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS CINCINNATI SUB-ZERO PRODUCTS, INC 510(k) NO: K101148(TRADITIONAL)
ATTN: STEVEN J BERKE PHONE NO : 513 772 8810 12011 MOSTELLER ROAD SE DECISION MADE: 01-OCT-10 CINCINNATI OH 45241 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS ZIMMER, INC. 510(k) NO: K101622(TRADITIONAL)
ATTN: DANIEL J WILLIMAN PHONE NO : 574 371 8065 P.O. BOX 708 SE DECISION MADE: 01-OCT-10 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT BICON, LLC 510(k) NO: K101849(TRADITIONAL) ATTN: VINCENT MORGAN, D.M.D. PHONE NO : 617 390 4363 501 ARBORWAY SE DECISION MADE: 01-OCT-10 BOSTON MA 02130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC.510(k) NO: K102216(TRADITIONAL)
ATTN: KATHRYN STINSON PHONE NO : 314 993 0003 13723 RIVERPORT DR SUITE 100 SE DECISION MADE: 01-OCT-10 MARYLAND HEIGHTS MO 63043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D SCANNER, MODEL 1230 SUN NUCLEAR CORP. 510(k) NO: K101992(TRADITIONAL)
ATTN: NOEL DOWNEY PHONE NO : 321 259 6862 425-A PINEDA COURT SE DECISION MADE: 01-OCT-10 MELBOURNE FL 32940 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT ZIMMER DENTAL INC. 510(k) NO: K101880(TRADITIONAL)
ATTN: MELISSA BURBAGE PHONE NO : 790 929 4300 1900 ASTON AVE. SE DECISION MADE: 01-OCT-10 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM WIPRO GE HEALTHCARE PRIVATE, LTD. 510(k) NO: K102104(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 01-OCT-10 WWAUWATOSA WI 53236 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 BIONOSTICS, INC. 510(k) NO: K101831(TRADITIONAL)
ATTN: MINNA RANNIKKO PHONE NO : 978 772 7070 7 JACKSON RD. SE DECISION MADE: 01-OCT-10 DEVENS MA 01434 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XELIS DENTAL INFINITT CO., LTD. 510(k) NO: K102684(TRADITIONAL)
ATTN: TRISTAN CHOI PHONE NO : 822 219 46673 12F DAERUNG POST TOWER III 182-4 GSE DECISION MADE: 01-OCT-10 SEOUL KS 152-050 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM SKELETAL DYNAMICS, LLC 510(k) NO: K092723(TRADITIONAL)
ATTN: JOSEPH M AZARY PHONE NO : 203 922 0105 80 SHELDON TECHNOLOGY CENTER SE DECISION MADE: 04-OCT-10 SHELTON CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMANOSITY CELEBRITY, MODEL 204 LUMANOSITY, INC 510(k) NO: K100213(TRADITIONAL) ATTN: JEFF PROVISSIERO PHONE NO : 888 344 0005 11271 VENTURA BLVD SUITE 212 SE DECISION MADE: 04-OCT-10 STUDIO CITY CA 91604 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) EXACT MEDICAL MANUFACTURING, INC 510(k) NO: K101598(TRADITIONAL)
ATTN: ROBERT O DEAN PHONE NO : 716 440 7362 1083 DELAWARE AVE SE DECISION MADE: 04-OCT-10 BUFFALO NY 14209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CASPIAN SPINAL SYSTEM K2M, INC. 510(k) NO: K101084(TRADITIONAL)
ATTN: NANCY GIEZEN PHONE NO : 703 777 3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 04-OCT-10 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIP'R MANTIS POWERED WHEELCHAIR GLOBAL FABTECH WHEELCHAIR (SHANGHA510(k) NO: K102355(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 16F-2 (16A), NO.462, SEC.2, CHONGDSE DECISION MADE: 04-OCT-10 TAICHUNG, TAIWAN (CHINA) TW 406510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIP'R3/ ZIP'R3 XTRA SCOOTER GLOBAL FABTECH WHEELCHAIR (SHANGHA510(k) NO: K102358(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 16F-2 (16A), NO.462, SEC.2, CHONGDSE DECISION MADE: 04-OCT-10 TAICHUNG, TAIWAN (CHINA) TW 406510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIP'R4/ ZIP'R4 XTRA SCOOTER GLOBAL FABTECH WHEELCHAIR (SHANGHA510(k) NO: K102361(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396 16F-2 (16A), NO.462, SEC.2, CHONGDSE DECISION MADE: 04-OCT-10 TAICHUNG, TAIWAN (CHINA) TW 406510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIANGSU HUAYUAN GLOVES CO., LTD. 510(k) NO: K102362(TRADITIONAL)
ATTN: YU BANG TING PHONE NO : 865 125 8415962 NO.68 JINGYI ROAD, CHENGDONG NEW DSE DECISION MADE: 04-OCT-10 DONGTAI CH 224249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRETCH VINYL EXAMINATION GLOVE POWDER FREE SHANDONG BLUE SAIL INNOVATION CO.,510(k) NO: K102160(TRADITIONAL)
ATTN: YONGCHEN ZHANG PHONE NO : 865 363 658588 EAST SIDE OF XING'AN ROAD, DONGCHESE DECISION MADE: 04-OCT-10 WEIFANG, SHANDONG CH 262600 510(k) STATEMENT DEVICE: MIRADA RT MIRADA MEDICAL LTD. 510(k) NO: K102687(TRADITIONAL)
ATTN: GWILYM OWEN PHONE NO : 440 186 5811172 MILL STREET INNOVATION HOUSE SE DECISION MADE: 04-OCT-10 OXFORD, OXFORDSHIRE UK OX2 0JX 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLUE SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K102096(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE. SE DECISION MADE: 04-OCT-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN FUQIANG GLOVE CO., LTD. 510(k) NO: K102431(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 ROOM 1606 BLDG. 1 JIANXIANG YUAN NSE DECISION MADE: 04-OCT-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUSIGNAL SPO2 FINGERTIP SENSOR GE HEALTHCARE FINLAND OY 510(k) NO: K101871(TRADITIONAL) ATTN: TOMMI JOKINIEMI PHONE NO : 358 103 9411 KUORTANEENKATU 2 SE DECISION MADE: 04-OCT-10 HELSINKI FI FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NO!NO! SKIN RADIANCY (ISRAEL) LTD. 510(k) NO: K102477(TRADITIONAL)
ATTN: ROTHMAN JULIA PHONE NO : 972 9 7757500 5 HANAGAR STREET SE DECISION MADE: 04-OCT-10 HOD HASHARON IS 45240 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD 510(k) NO: K101828(TRADITIONAL)
ATTN: CHO SOW FONG PHONE NO : 603 329 11600 LOT 6487, BATU 5 3/4, SEMENTA JALASE DECISION MADE: 04-OCT-10 KLANG MY 42100 510(k) STATEMENT DEVICE: KAIYANG ALUMINUM WHEELCHAIR GUANGDONG KAIYANG MEDICAL TECHNOLO510(k) NO: K101998(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829 YANFENG INDUSTRIAL AREA, DALI, NANSE DECISION MADE: 04-OCT-10 FOSHAN CH 528231 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAIYANG STEEL WHEELCHAIR GUANGDONG KAIYANG MEDICAL TECHNOLO510(k) NO: K101999(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 866 352 08829 YANFENG INDUSTRIAL AREA, DALI, NANSE DECISION MADE: 04-OCT-10 FOSHAN CH 528231 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IDEV TECHNOLOGIES, INC. 510(k) NO: K093893(TRADITIONAL)
ATTN: DARLENE GARNER PHONE NO : 281 525 2000 253 MEDICAL CENTER BLVD SE DECISION MADE: 05-OCT-10 WEBSTER TX 77598 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TDS PRECISION DENTAL BAR POU YU BIOTECHNOLOGY CO., LTD. 510(k) NO: K100356(TRADITIONAL)
ATTN: DANIEL TASO PHONE NO : 886 476 856605122 NO. 6, FUGONG RD. SE DECISION MADE: 05-OCT-10 FUSING TOWNSHIP, CHANGHUA CTY T510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XTRA AUTOTRANSFUSION SYSTEM SORIN GROUP ITALIA S.R.L. 510(k) NO: K101586(TRADITIONAL)
ATTN: BARRY SALL PHONE NO : 781 434 4742 195 WEST STREET SE DECISION MADE: 05-OCT-10 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMC SURGICAL DRAPE INTERNATIONAL MEDSURG CONNECTION 510(k) NO: K100991(TRADITIONAL)
ATTN: PETER KIM PHONE NO : 847 619 9926 935 N. PLUM GROVE ROAD, SUITE F SE DECISION MADE: 05-OCT-10 SCHAUMBURG IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 BOSTON SCIENTIFIC CORP. 510(k) NO: K101657(ABBREVIATED)
ATTN: ASHLEY PYLE PHONE NO : 508 683 4359 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 05-OCT-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANTI-HAV ROCHE PROFESSIONAL DIAGNOSTICS 510(k) NO: K100903(TRADITIONAL) ATTN: KELLY FRENCH PHONE NO : 317 521 3208 9115 HAGUE ROAD P.O. BOX 50410 SE DECISION MADE: 05-OCT-10 INDIANAPOLIS IN 510(k) STATEMENT DEVICE: ELECSYS CA 19-9 CALCHECK 5 ROCHE DIAGNOSTICS CORP. 510(k) NO: K101365(TRADITIONAL)
ATTN: KELLY O'MAINE ADAMS PHONE NO : 317 521 3577 9115 HAGUE RD PO BOX 50416 SE DECISION MADE: 05-OCT-10 INDIANAPOLIS IN 46250 0457 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE ECHOPAC MODEL BT10 GE VINGMED ULTRASOUND AS 510(k) NO: K101324(TRADITIONAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 W INNOVATION DR. RP-2138 SE DECISION MADE: 05-OCT-10 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS CEA CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K101856(TRADITIONAL)
ATTN: JASON FISHER PHONE NO : 800 428 5074 9115 HAGUE RD SE DECISION MADE: 05-OCT-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO IMRIS, INC. 510(k) NO: K101813(TRADITIONAL) ATTN: THOMAS M TSAKERIS PHONE NO : 301 330 2076 16809 BRIARDALE ROAD SE DECISION MADE: 05-OCT-10 ROCKVILLE MD 20855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K101809(TRADITIONAL)
ATTN: STACEY DOLAN PHONE NO : 610 240 3843 201 GREAT VALLEY PARKWAY SE DECISION MADE: 05-OCT-10 MALVERN PA 19355 1307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIE SCINTRON GAMMA CAMERA SYSTEMS MIE GMBH 510(k) NO: K101768(TRADITIONAL)
ATTN: THOMAS KUHL PHONE NO : 041 949 97737 HAUPTSTR. 112 SE DECISION MADE: 05-OCT-10 SETH GM D-23845 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOURNEY UNICONDYLAR TIBIAL BASEPLATES SMITH & NEPHEW, INC. 510(k) NO: K102069(TRADITIONAL)
ATTN: GINO ROUSS PHONE NO : 901 399 6707 1450 BROOKS ROAD SE DECISION MADE: 05-OCT-10 MEMPHIS TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO DYNAMICS, VERSION 9.0 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K102150(TRADITIONAL)
ATTN: YURI IKEDA PHONE NO : 734 205 2442 400 W. MORGAN ROAD SE DECISION MADE: 05-OCT-10 ANN ARBOR MI 48108 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 MEDIEN INTERNATIONAL CO., LTD 510(k) NO: K093816(TRADITIONAL)
ATTN: CHARLES MACK PHONE NO : 541 376 5063 77325 JOYCE WAY SE DECISION MADE: 05-OCT-10 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS CHINA CO., LTD.510(k) NO: K102256(TRADITIONAL)
ATTN: YALAN WU PHONE NO : 865 108 5278652 NO. 19 CHANGJIANG ROAD NATIONAL HISE DECISION MADE: 05-OCT-10 WUXI, JIANGSU PROVINCE CH 21402510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE LOGIQ P6/P6 PRO GE HEALTHCARE 510(k) NO: K101874(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 05-OCT-10 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT ATRIUM MEDICAL CORP. 510(k) NO: K102596(SPECIAL)
ATTN: RAYMOND J KELLY PHONE NO : 603 880 1433 5 WENTWORTH DR. SE DECISION MADE: 05-OCT-10 HUDSON NH 03051 510(k) STATEMENT DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K102094(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909 590 1611 DONGGAO INDUSTRIAL ZONE SE DECISION MADE: 05-OCT-10 ZANHUANG, HEBEI CH 050000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PARADIGM INTERSPINOUS FUSION PLATE PARADIGM SPINE, LLC 510(k) NO: K093438(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 06-OCT-10 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOPANTOMOGRAPH OP300 INSTRUMENTARIUM DENTAL, PALODEX GR510(k) NO: K093683(TRADITIONAL)
ATTN: MATTI TULIKOURA PHONE NO : 358 102 702000 NAHKELANTIE 160 SE DECISION MADE: 06-OCT-10 TUUSULA, FINLAND FI 04300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUMED WRIST ARTHRODESIS PLATE SYSTEM ACUMED LLC 510(k) NO: K100123(TRADITIONAL)
ATTN: LINO TSAI PHONE NO : 503 627 9957 5885 NW CORNELIUS PASS RD. SE DECISION MADE: 06-OCT-10 HILLSBORO OR 97124 9432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONSENSUS CS2 PLUS ACETABULAR INSERT CONSENSUS ORTHOPEDICS, INC 510(k) NO: K100933(SPECIAL)
ATTN: LUKE ROSE PHONE NO : 916 355 7156 1115 WINFIELD WAY SUITE 100 SE DECISION MADE: 06-OCT-10 ELDORADO HILLS CA 95762 9623 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES PROFIT POINT MANUFACTURING SDN BHD510(k) NO: K101760(TRADITIONAL)
ATTN: ROBERT HILL PHONE NO : 607 787 9786 JALAN MERSING KAWASAN PERIDUSTRIA SE DECISION MADE: 06-OCT-10 KLUANG, JOHOR MY 86000 510(k) STATEMENT DEVICE: GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES GRAND WORK PLASTIC PRODUCTS CO., L510(k) NO: K102089(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAFER AVE. SE DECISION MADE: 06-OCT-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERFUSE T INVERTEBRAL BODY FUSION DEVICE VERTEBRAL TECHNOLOGIES, INC. 510(k) NO: K102277(SPECIAL)
ATTN: SURESH GHAI PHONE NO : 952 912 5400 5909 BAKER ROAD SUITE 550 SE DECISION MADE: 06-OCT-10 MINNETONKA MN 55345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOMEGA STC CONSULTING LLC 510(k) NO: K102006(TRADITIONAL)
ATTN: R. SAM NIEDBALA PHONE NO : 610 597 5501 4093 MAULFAIR DRIVE SE DECISION MADE: 06-OCT-10 ALLENTOWN PA 18103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES PRESTIGE AMERITECH 510(k) NO: K102092(ABBREVIATED)
ATTN: BARARA MCCARTY PHONE NO : 817 427 2700 7201 IRON HORSE BLVD SE DECISION MADE: 06-OCT-10 NORTH RICHLAND HILLS TX 76180 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES HONG DI PLASTIC PRODUCTS CO, LTD. 510(k) NO: K102099(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE. SE DECISION MADE: 06-OCT-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HSV STRAW CRYO BIO SYSTEM 510(k) NO: K092398(TRADITIONAL)
ATTN: DAVE BALDING PHONE NO : 949 412 0619 26552 TAMPICO PLACE SE DECISION MADE: 06-OCT-10 MISSION VIEJO CA 92691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULISA PR3 ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K092600(TRADITIONAL) ATTN: KEVIN LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 07-OCT-10 BUFFALO NY 14228 2120 510(k) STATEMENT DEVICE: IMMULISA ANCA SCREEN ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K092601(TRADITIONAL) ATTN: KEVIN LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 07-OCT-10 BUFFALO NY 14228 2120 510(k) STATEMENT DEVICE: IMMULISA MPO ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K092599(TRADITIONAL) ATTN: KEVIN LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 07-OCT-10 BUFFALO NY 14228 510(k) STATEMENT DEVICE: DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE BIONEN S.A.S. 510(k) NO: K092973(TRADITIONAL)
ATTN: ALLISON SCOTT PHONE NO : 317 569 9500 11460 N. MERIDIAN ST., STE 150 SE DECISION MADE: 07-OCT-10 CARMEL IN 46032 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 SOLARIS MEDICAL TECHNOLOGY, INC. 510(k) NO: K100077(TRADITIONAL)
ATTN: RACHEL CHENG PHONE NO : 650 588 3890 400 OYSTER POINT BLVD. SUITE 534 SE DECISION MADE: 07-OCT-10 SOUTH SAN FRANCISCO CA 94080 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE MIDWEST REPROCESSING CENTER LLC 510(k) NO: K101280(TRADITIONAL)
ATTN: JEROME JAMES PHONE NO : 205 314 3920 434 INDUSTRIAL LANE SE DECISION MADE: 07-OCT-10 BIRMINGHAM AL 35211 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ GE HEALTHCARE 510(k) NO: K101166(TRADITIONAL)
ATTN: BRYAN BEHN PHONE NO : 414 721 4214 9900 INNOVATION DRIVE SE DECISION MADE: 07-OCT-10 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D2RF DIGITAL DYNAMIC REMOTE SYSTEM STEPHANIX RADIOLOGICAL SYSTEMS 510(k) NO: K102529(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8870 RAVELLO COURT SE DECISION MADE: 07-OCT-10 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLPARA, VERSION 1.3 MAKATINA TECHNOLOGY 510(k) NO: K102556(TRADITIONAL)
ATTN: SHEILA W PICKERING PHONE NO : 650 279 0668 2081 LONGDEN CIRCLE SE DECISION MADE: 07-OCT-10 LOS ALTOS CA 94024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS IGE CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K102269(TRADITIONAL) ATTN: SARAH BAUMANN PHONE NO : 317 521 3952 9115 HAGUE ROAD SE DECISION MADE: 07-OCT-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GIRAFFE2 KERR CORPORATION 510(k) NO: K102133(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 07-OCT-10 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELERADPRO VIDAR SYSTEMS CORP. 510(k) NO: K102476(SPECIAL)
ATTN: CARRIE L BRANCART PHONE NO : 703 471 7070 365 HERNDON PARKWAY SE DECISION MADE: 07-OCT-10 HERNDON VA 20170 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM MERETE MEDICAL GMBH 510(k) NO: K101939(TRADITIONAL)
ATTN: DONNA COLEMAN PHONE NO : 914 967 1532 49 PURCHASE STREET SE DECISION MADE: 07-OCT-10 RYE NY 10580 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. 510(k) NO: K102582(TRADITIONAL)
ATTN: RUTH WU PHONE NO : 800 251 7488 1100 1ST AVENUE SUITE 100 SE DECISION MADE: 07-OCT-10 KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER ETHICON ENDO-SURGERY, INC. 510(k) NO: K102632(TRADITIONAL)
ATTN: RENEE ROWE PHONE NO : 513 337 8243 4545 CREEK RD. SE DECISION MADE: 07-OCT-10 CINCINNATI OH 45242 2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARSTASIS ACCESS SYSTEM ARSTASIS, INC. 510(k) NO: K102728(SPECIAL)
ATTN: DEBRA COGAN PHONE NO : 650 508 1549 1021 HOWARD AVE SUITE C SE DECISION MADE: 07-OCT-10 SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I-LOGIC INREACH SYSTEM SUPERDIMENSION, LTD. 510(k) NO: K102604(SPECIAL)
ATTN: JONATHAN KOVACH PHONE NO : 763 210 4015 161 CHESHIRE LANE NORTH, SUITE 100SE DECISION MADE: 07-OCT-10 MINNEAPOLIS MN 55441 5433 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMEL SPECTRA MRSA REMEL, INC. 510(k) NO: K092407(TRADITIONAL) ATTN: MARY ANN SILVIUS PHONE NO : 913 895 4054 12076 SANTA FE DR. SE DECISION MADE: 08-OCT-10 LENEXA KS 66215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEXNRG RIDER MEDICNRG LTD. 510(k) NO: K101177(TRADITIONAL)
ATTN: GEORGE HATTUB PHONE NO : 508 479 6116 291 HILLSIDE AVE. SE DECISION MADE: 08-OCT-10 SOMERSET MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD LANG DENTAL MFG. CO., INC. 510(k) NO: K100653(TRADITIONAL)
ATTN: DAVID LANG PHONE NO : 847 215 6622 175 MESSNER DR. SE DECISION MADE: 08-OCT-10 WHEELING IL 60090 0969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE BETTER CARE PLASTIC TECHNOLOGY CP.510(k) NO: K101594(TRADITIONAL)
ATTN: JIE LIU\ PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 08-OCT-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE C.R. BARD INC., BARD ELECTROPHYSIO510(k) NO: K101331(TRADITIONAL)
ATTN: ANASTASIA C RANDALL PHONE NO : 978 323 2348 55 TECHNOLOGY DR. SE DECISION MADE: 08-OCT-10 LOWELL MA 01851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HT III SA FIXTURE SYSTEM HIOSSEN INC. 510(k) NO: K101096(TRADITIONAL)
ATTN: PATRICK LIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DRIVE SE DECISION MADE: 08-OCT-10 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURMARK BIOPSY SITE MARKING SYSTEM SUROS SURGICAL SYSTEMS, INC, A HOL510(k) NO: K102608(SPECIAL)
ATTN: ALYSSA M LOBO PHONE NO : 877 887 8767 6100 TECHNOLOGY CENTER DR. SE DECISION MADE: 08-OCT-10 INDIANAPOLIS IN 46278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLUE SAIL INNOVATION SHANDONG BLUE SAIL INNOVATION CO.,510(k) NO: K102161(TRADITIONAL)
ATTN: YONGCHEN ZHANG PHONE NO : 865 363 658588 EAST SIDE OF XING'AN ROAD, DONGCHESE DECISION MADE: 08-OCT-10 WEIFANG, SHANDONG CH 262600 510(k) STATEMENT DEVICE: AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K102059(TRADITIONAL)
ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWY P.O. BOX 610SE DECISION MADE: 08-OCT-10 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSTENE CT, AOC CT, OSTEOTENE, CERETENE CEREMED, INC. 510(k) NO: K102071(TRADITIONAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310 815 2125 3643 LENAWEE AVE. SE DECISION MADE: 08-OCT-10 LOS ANGELES CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUOLINK II BISCO, INC. 510(k) NO: K101787(TRADITIONAL)
ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 08-OCT-10 SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IONOLUX PRO VOCO GMBH 510(k) NO: K102450(SPECIAL)
ATTN: MANFRED T PLAUMANN PHONE NO : 49 472 17190 ANTON-FLETTNER-STR 1-3 SE DECISION MADE: 08-OCT-10 CUXHAVEN GM D-27472 510(k) STATEMENT DEVICE: MODIFICATION TO:EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K101933(SPECIAL) ATTN: DAPHNEY GERMAIN PHONE NO : 508 880 8395 325 PARAMOUNT DR. SE DECISION MADE: 10-OCT-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGSYS KEOSYS S.A.S. 510(k) NO: K102000(TRADITIONAL)
ATTN: ANTHONY MOTTIER PHONE NO : 33 2 40922613 IMPASSE AUGUSTIN FRESNEL, Z.A. DU SE DECISION MADE: 12-OCT-10 SAINT-HERBLAIN FR 44815 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMCOOLSPAD EMCOOLS EMERGENCY MEDICAL COOLING 510(k) NO: K100071(TRADITIONAL)
ATTN: MICHAEL KUEHLING PHONE NO : 43 225 2890152161 BRUCKNERSTRASSE 6/7A 1040 WIEN SE DECISION MADE: 12-OCT-10 VIENNA AU 1040 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K100011(TRADITIONAL) ATTN: ROBERT PETRY PHONE NO : 649 574 0100 15 MAURICE PAYKEL PLACE SE DECISION MADE: 12-OCT-10 EAST TAMAKI NZ 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXSALT WOUND DRESSING EXCITON TECHNOLOGIES INC. 510(k) NO: K100580(TRADITIONAL)
ATTN: JOHN SIMON PHONE NO : 780 248 5868 SUITE 4232, 10230 JASPER AVE SE DECISION MADE: 12-OCT-10 EDMONTON, ALBERTA CA T5J 4P6 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM EXTREMITY MEDICAL LLC 510(k) NO: K101700(TRADITIONAL) ATTN: JAMY GANNOE PHONE NO : 973 588 8980 300 INTERPACE PARKWAY SUITE 410 SE DECISION MADE: 12-OCT-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K102671(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925 602 8157 4040 NELSON AVE. SE DECISION MADE: 12-OCT-10 CONCORD CA 94520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 ZOLL CIRCULATION 510(k) NO: K101987(TRADITIONAL)
ATTN: SAM NANAVATI PHONE NO : 408 541 2140 650 ALMANOR AVENUE SE DECISION MADE: 12-OCT-10 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMALL PLATEAU SPACER SYSTEM LIFE SPINE 510(k) NO: K093093(TRADITIONAL)
ATTN: CHARLES P GILL PHONE NO : 847 884 6117 2401 W. HASSELL RD. SUITE 1535 SE DECISION MADE: 13-OCT-10 HOFFMAN ESTATES IL 60169 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA FLASH H-TTG IGA INOVA DIAGNOSTICS, INC. 510(k) NO: K094060(TRADITIONAL) ATTN: TANA KEIVENS PHONE NO : 858 586 9900 9900 OLD GROVE RD. SE DECISION MADE: 13-OCT-10 SAN DIEGO CA 92131 1638 510(k) STATEMENT DEVICE: SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI "R" SERIES SUTURE PLACEME LSI SOLUTIONS, INC. 510(k) NO: K100593(TRADITIONAL)
ATTN: PETER SPATH PHONE NO : 585 869 6641 7796 VICTOR-MENDON RD. SE DECISION MADE: 13-OCT-10 VICTOR NY 14564 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM GE VINGMED ULTRASOUND AS 510(k) NO: K101149(SPECIAL)
ATTN: BRYAN BEHN PHONE NO : 473 302 1269 9900 W INNOVATION DR. RP-2138 SE DECISION MADE: 13-OCT-10 WAUWATOSA WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX MEDTRONIC INC. 510(k) NO: K101271(SPECIAL)
ATTN: JEFFREY L KOLL PHONE NO : 763 514 9842 8200 CORAL SEA STREET NE SE DECISION MADE: 13-OCT-10 MOUNDS VIEW MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIXPLORER SUPERSONIC IMAGINE 510(k) NO: K102041(TRADITIONAL)
ATTN: JACQUES SOUQUET PHONE NO : 011 334 42992424 510 RUE RENE DESCARTES SE DECISION MADE: 13-OCT-10 AIX-EN-PROVENCE CEDEX FR 13857510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REL-K ARTIFICAL LIMB PROSTHESIS RIZZOLI ORTOPEDICA S.P.A. 510(k) NO: K101859(TRADITIONAL)
ATTN: DIANE C TIERNAN, MS RAC PHONE NO : 617 510 5595 58A BATES ROAD SE DECISION MADE: 13-OCT-10 WATERTOWN MA 02472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE MIRADOR BIOMEDICAL, INC. 510(k) NO: K101518(TRADITIONAL)
ATTN: JUSTIN HULVERSHORN MD, PHDPHONE NO : 206 295 3372 2815 WASTLAKE AVENUE SUITE 300 SE DECISION MADE: 13-OCT-10 SEATTLE WA 98102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) COVIDIEN LLC, FORMERLY REGISTERED 510(k) NO: K102325(TRADITIONAL)
ATTN: NISHITH DESAI PHONE NO : 203 492 6339 60 MIDDLETOWN AVE SE DECISION MADE: 13-OCT-10 NORTH HAVEN CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) ATOS MEDICAL AB 510(k) NO: K092593(TRADITIONAL) ATTN: FERENC DAHNER PHONE NO : 46 415 19800 KRAFTGATAN 8 SE DECISION MADE: 14-OCT-10 HORBY SW SE-24222 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOSSEOUS DENTAL IMPLANT SOUTHERN IMPLANTS, INC. 510(k) NO: K093562(TRADITIONAL)
ATTN: MICHAEL KEHOE PHONE NO : 949 273 8505 5 HOLLAND BLDG 209 SE DECISION MADE: 14-OCT-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KYPHON XPANDER II INFLATABLE BONE TAMP MEDTRONIC 510(k) NO: K101864(TRADITIONAL)
ATTN: HEINZ STENEBERG PHONE NO : 408 548 6500 1221 CROSSMAN AVE. SE DECISION MADE: 14-OCT-10 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM SPINAL ELEMENTS, INC. 510(k) NO: K101848(TRADITIONAL)
ATTN: BENJAMIN A KIMBALL PHONE NO : 760 607 0121 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 14-OCT-10 CARLSBAD CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RANDOX BENZODIAZEPINE ASSAY RANDOX LABORATORIES, LTD. 510(k) NO: K092274(TRADITIONAL) ATTN: PAULINE ARMSTRONG PHONE NO : 44 28 94422413 55 DIAMOND RD. SE DECISION MADE: 15-OCT-10 CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAPSS SPINAL SYSTEM ROBERT REID INC. 510(k) NO: K093833(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 15-OCT-10 CHESTERLAND OH 44026 2141 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT ASCEND EAGLE, INC. 510(k) NO: K101351(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775 342 2612 198 AVE DE LA DEMERALD SE DECISION MADE: 15-OCT-10 SPARKS NV 94589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TARGET DETACHABLE COIL BOSTON SCIENTIFIC CORP. 510(k) NO: K102672(SPECIAL)
ATTN: JAMES LEATHLEY PHONE NO : 510 440 7836 47900 BAYSIDE PARKWAY SE DECISION MADE: 15-OCT-10 FREMONT CA 94538 6515 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOSURE ROD LENS SCOPE SEALS INTERLACE MEDICAL, INC. 510(k) NO: K102686(SPECIAL)
ATTN: JOHN J VOZELLA PHONE NO : 508 875 1343 139 NEWBURY STREET SE DECISION MADE: 15-OCT-10 FRAMINGHAM MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROTEGRITY SMT LATEX SURGICALGLOVES CARDINAL HEALTH, INC. 510(k) NO: K101811(TRADITIONAL)
ATTN: TATYANA BOGDAN PHONE NO : 847 887 2325 1500 WAUKEGAN ROAD SE DECISION MADE: 15-OCT-10 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ELECTRONIC BLOOD PRESSURE MONITOR SHENZHEN PANGO ELECTRONIC CO., LTD510(k) NO: K102920(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 122 815850 P.O. BOX 237-023 SE DECISION MADE: 15-OCT-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 ST. JUDE MEDICAL 510(k) NO: K101955(TRADITIONAL)
ATTN: WENDY PINOR PHONE NO : 651 756 5223 14901 DEVEAU PL. SE DECISION MADE: 15-OCT-10 MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINPOINTE FOOTLASER PINPOINTE USA, INC. 510(k) NO: K093547(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925 895 1200 3637 BERNAL AVE. SE DECISION MADE: 15-OCT-10 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K102774(SPECIAL)
ATTN: JUDI SMITH PHONE NO : 410 592 2060 P.O. BOX 103 SE DECISION MADE: 15-OCT-10 BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LDR SPINE USA SPINETUNE TL SPINAL SYSTEM LDR SPINE USA 510(k) NO: K102331(SPECIAL)
ATTN: BECKINAM NOWATZKE PHONE NO : 512 344 3407 4030 WEST BRAKER LANE SUITE 360 SE DECISION MADE: 15-OCT-10 AUSTIN TX 78759 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BEYONDIMAGE WORKSTATION NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K102435(TRADITIONAL)
ATTN: TIAN YUEHUI PHONE NO : 86 24 83660646 NO. 16, SHIJI ROAD HUNNAN INDUSRTISE DECISION MADE: 15-OCT-10 SHENYANG, LIAONING CH 110179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RPM RESPIRATORY GATING SYSTEM VARIAN MEDICAL SYSTEMS 510(k) NO: K102024(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650 424 5731 911 HANSEN WAY SE DECISION MADE: 15-OCT-10 PALO ALTO CA 94304 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PINPOINTE FOOTLASER MODEL 6W, 30W, 100W INCISIVE, INC. (FORMERLY NAMED INC510(k) NO: K093545(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925 895 1200 3637 BERNAL AVENUE SE DECISION MADE: 15-OCT-10 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 VITALOGRAPH(IRELAND) LTD. 510(k) NO: K100687(TRADITIONAL)
ATTN: TOM J HEALY PHONE NO : 353 65 6864100 ENNIS INDUSTRIAL ESTATE GORT ROAD SE DECISION MADE: 16-OCT-10 ENNIS, CO. CLARE EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REALSEAL XT SEALER KERR CORPORATION 510(k) NO: K102163(TRADITIONAL)
ATTN: WENDY GARMEN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 16-OCT-10 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K093471(TRADITIONAL)
ATTN: CRYSTAL DIZOL PHONE NO : 424 218 8381 2151 E. GRAND AVE. SE DECISION MADE: 18-OCT-10 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISTEO OWANDY 510(k) NO: K093105(ABBREVIATED)
ATTN: JAY MANSOUR PHONE NO : 678 908 8180 845 ARONSON LAKE COURT SE DECISION MADE: 18-OCT-10 ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDTOX BUPRENORPHINE TEST MEDTOX DIAGNOSTICS, INC. 510(k) NO: K100951(TRADITIONAL)
ATTN: PHILLIP HARTZOG PHONE NO : 336 226 6311 1238 ANTHONY RD. SE DECISION MADE: 18-OCT-10 BURLINGTON NC 27215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LENSX LASER SYSTEM LENSX LASERS, INC. 510(k) NO: K101626(TRADITIONAL) ATTN: JUDY GORDON PHONE NO : 949 715 0609 733 BOLSANA DR. SE DECISION MADE: 18-OCT-10 LAGUNA BEACH CA 92651 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 AGAMATRIX 510(k) NO: K101597(SPECIAL)
ATTN: CONNIE HERTEL PHONE NO : 603 328 6000 10 MAOR PARKWAY SE DECISION MADE: 18-OCT-10 SALEM NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PMC LAPAROSCOPIC INSTRUMENTS PMC MEDICAL GMBH 510(k) NO: K101193(TRADITIONAL)
ATTN: ANDREA PECSI PHONE NO : 497 462 924051 SCHWARZWAIDSTRASSE 5 SE DECISION MADE: 18-OCT-10 TUTTLINGEN GM 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESCAPE MONITOR B650 GE HEALTHCARE FINLAND OY 510(k) NO: K102239(TRADITIONAL)
ATTN: PAIVI ROIHA PHONE NO : 358 103 943731 KUORTANEENKATU 2 SE DECISION MADE: 18-OCT-10 HELSINKI FI FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY CYLEX, INC. 510(k) NO: K101911(SPECIAL)
ATTN: JUDI SMITH PHONE NO : 410 592 2060 P.O. BOX 103 SE DECISION MADE: 18-OCT-10 BALDWIN MD 21013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIVEWIRE ELECTOPHYSIOLOGY CATHETER ST. JUDE MEDICAL 510(k) NO: K102721(SPECIAL)
ATTN: NICOLE BOWDEN PHONE NO : 651 765 5162 14901 DEVEAU PL. SE DECISION MADE: 18-OCT-10 MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RE-TRACE URETERAL ACCESS SHEATH COLOPLAST A/S 510(k) NO: K102485(TRADITIONAL)
ATTN: BRIAN SCHMIDT PHONE NO : 612 302 4987 1601 WEST RIVER ROAD N SE DECISION MADE: 18-OCT-10 MINNEAPOLIS MN 55411 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HRV ACQUIRE WR MEDICAL ELECTRONICS CO. 510(k) NO: K092809(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608 877 2635 800 LAVANGER LANE SE DECISION MADE: 19-OCT-10 STOUGHTON WI 53589 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-MODULAR REVERSE SHOLDER BIOMET MANUFACTURING CORP. 510(k) NO: K093803(TRADITIONAL)
ATTN: PATRICIA SANDBORN BERES PHONE NO : 574 267 6639 56 EAST BELL DRIVE SE DECISION MADE: 19-OCT-10 WARSAW IN 46582 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX GERATHERM MEDICAL AG 510(k) NO: K093244(TRADITIONAL)
ATTN: ANDREA PECSI PHONE NO : 004 974 62924051 SCHWARZWALDSTRASSE 5 SE DECISION MADE: 19-OCT-10 TUTTLIGEN GM 78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 MEDIPURPOSE PTE. LTD. 510(k) NO: K101417(ABBREVIATED)
ATTN: JULIE STEPHENS PHONE NO : 678 513 0693 111 LAUREL RIDGE DRIVE SE DECISION MADE: 19-OCT-10 ALPHARETTA GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C SHANTOU I NSTITUTE OF ULTRASONIC I510(k) NO: K102023(TRADITIONAL) ATTN: BOB LEIKER PHONE NO : 925 556 1302 7263 CRONIN CIRCLE SE DECISION MADE: 19-OCT-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASOGRAD DVT COMPRESSION GARMENT COMPRESSION THERAPY CONCEPTS 510(k) NO: K102732(SPECIAL)
ATTN: LEONARD NASS PHONE NO : 732 544 0800 35 JAMES WAY SE DECISION MADE: 19-OCT-10 EATONTOWN NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN LLC 510(k) NO: K102737(SPECIAL)
ATTN: MELODY BI PHONE NO : 508 261 6325 15 HAMPSHIRE ST SE DECISION MADE: 19-OCT-10 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 SMITHS MEDICAL ASD, INC. 510(k) NO: K092256(TRADITIONAL)
ATTN: PAT MCLEISH PHONE NO : 781 878 8011 160 WEYMOUTH ST. SE DECISION MADE: 20-OCT-10 ROCKLAND MA 02370 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYRUS ACMI BIOCOAG PROBE GYRUS ACMI, INC. 510(k) NO: K092571(TRADITIONAL)
ATTN: LORRAINE CALZETTA PHONE NO : 508 804 2752 136 TURNPIKE RD. SE DECISION MADE: 20-OCT-10 SOUTHBOROUGH MA 01772 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXELINT ALUMINUM HUB BLUNT NEEDLES EXELINT INTERNATIONAL CO. 510(k) NO: K101309(TRADITIONAL)
ATTN: ARMAND HAMID PHONE NO : 310 649 0707 5840 W. CENTINELA AVE. SE DECISION MADE: 20-OCT-10 LOS ANGELES CA 90045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY OSCOR INC. 510(k) NO: K101497(TRADITIONAL)
ATTN: MILA DOSKOCIL PHONE NO : 727 937 2511 3816 DE SOTO BLVD. SE DECISION MADE: 20-OCT-10 PALM HARBOR FL 34683 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANO-CHECK AMI CTNI CARDIAC MARKER TEST NANO-DITECH CORPORATION 510(k) NO: K102131(SPECIAL)
ATTN: YOUNG HOON KIM PHONE NO : 609 409 0700 7 CLARKE DRIVE SUITE 3 SE DECISION MADE: 20-OCT-10 CRANBURY NJ 08512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT THYSSENKRUPP CETECO SRL 510(k) NO: K102088(SPECIAL)
ATTN: FABRIZIO FEDELE PHONE NO : 39 050 955111 VIA S.CANNIZZARO, 2 SE DECISION MADE: 20-OCT-10 PISA IT 56121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIPER SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K102701(SPECIAL)
ATTN: KEVIN G STEVENS PHONE NO : 508 977 6445 325 PARAMOUNT DR. SE DECISION MADE: 20-OCT-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-CATH TISSUE ANCHOR DELIVERY CATHETER USGI MEDICAL 510(k) NO: K102916(SPECIAL)
ATTN: MARY L MOONEY PHONE NO : 949 369 3890 1140 CALLE CORDILLERA SE DECISION MADE: 20-OCT-10 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC. 510(k) NO: K101843(TRADITIONAL)
ATTN: DAVID A GREER PHONE NO : 518 795 1676 14 PLAZA DRIVE SE DECISION MADE: 20-OCT-10 LATHAM NY 12110 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONTOURS VSP III VOLAR PLATING SYSTEM ORTHOFIX, INC. 510(k) NO: K101936(SPECIAL)
ATTN: MARY BIGGERS, RAC PHONE NO : 972 824 4624 1720 BRAY CENTRAL DR. SE DECISION MADE: 20-OCT-10 MCKINNEY TX 75069 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRAFIX TIBIAL SHEATH DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K102443(SPECIAL)
ATTN: DEEP PAL PHONE NO : 508 977 3998 325 PARAMOUNT DR. SE DECISION MADE: 20-OCT-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GALAXY LITE FUTURE MOBILITY HEALTHCARE INC. 510(k) NO: K102031(TRADITIONAL)
ATTN: ABDULSAMAD PANCHBHAYA PHONE NO : 905 671 1661 3223 ORLANDO DRIVE SE DECISION MADE: 20-OCT-10 MISSISSAUGA, ONTARIO CA L4V 1C5510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER CANNULATED SCREW SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. 510(k) NO: K102903(SPECIAL)
ATTN: EMILY M DOWNS PHONE NO : 906 225 5602 375 RIVER PARK CIRCLE SE DECISION MADE: 20-OCT-10 MARQUETTE MI 49855 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN NANO-DITECH CORPORATION 510(k) NO: K102441(SPECIAL) ATTN: YOUNG WOO KIM PHONE NO : 609 409 0700 7 CLARKE DRIVE SUITE 3 SE DECISION MADE: 20-OCT-10 CRANBURY NJ 08512 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARESCAPE MODEL V100 VITAL SIGNS MONITOR GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K102426(SPECIAL)
ATTN: MARY CARTER PHONE NO : 414 362 2626 8200 WEST TOWER AVE. SE DECISION MADE: 20-OCT-10 MILWAUKEE WI 53223 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHARMCARE TABLETOP PULSE OXIMETER CHARMCARE CO., LTD 510(k) NO: K092641(TRADITIONAL)
ATTN: JOYCE BANG PHONE NO : 714 525 0114 325 N. PUENTE ST. UNIT B SE DECISION MADE: 21-OCT-10 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMIN PRO VOCO GMBH 510(k) NO: K101104(TRADITIONAL)
ATTN: M. TH PLAUMANN PHONE NO : 494 721 719 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 21-OCT-10 CUXHAVEN GM D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXACTECH GPS BLUE ORTHO 510(k) NO: K100742(TRADITIONAL)
ATTN: ANTHONY BOYER PHONE NO : 334 765 49546 5 AVENUE DU GRAND SABLON SE DECISION MADE: 21-OCT-10 LA TRONCHE FR 38700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE DOXCYCLINE BIOMERIEUX, INC. 510(k) NO: K093076(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314 731 8386 595 ANGLUM RD. SE DECISION MADE: 21-OCT-10 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS CEFLA DENTAL GROUP 510(k) NO: K100960(TRADITIONAL)
ATTN: CYNTHIA J.M. NOLTE, PH.D. PHONE NO : 919 859 4207 49 PLAIN STREET SE DECISION MADE: 21-OCT-10 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 MEDIPURPOSE PTE. LTD. 510(k) NO: K101145(ABBREVIATED)
ATTN: JULIE STEPHENS PHONE NO : 678 513 0693 111 LAUREL RIDGE DRIVE SE DECISION MADE: 21-OCT-10 ALPHARETTA GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 ALCON RESEARCH, LTD. 510(k) NO: K101006(TRADITIONAL)
ATTN: MICHAEL BUENGER PHONE NO : 817 551 6810 6201 SOUTH FREEWAY SE DECISION MADE: 21-OCT-10 FORT WORTH TX 76134 2099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOND BONE M.I.S. IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K101014(TRADITIONAL)
ATTN: IMAN KHORSHID PHONE NO : 972 4 9016800 P.O. BOX 7 SE DECISION MADE: 21-OCT-10 BAR LEV INDUSTRIAL PARK IS 2015510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) TANGSHAN HENGDA PLASTIC PRODUCTS C510(k) NO: K102559(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 #209 BEI SI HUAN ZHONG ROAD RM 160SE DECISION MADE: 21-OCT-10 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 PHILIPS MEDIZINSYSTEME BOBLINGEN G510(k) NO: K102562(SPECIAL)
ATTN: ANDREAS SUCHI PHONE NO : 49 703 14631291 HEWLETT PACKARD STR. 2 SE DECISION MADE: 21-OCT-10 BOBLINGEN GM D 71034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) KAWASUMI LABORATORIES AMERICA, INC510(k) NO: K102890(SPECIAL)
ATTN: JACK PAVLO PHONE NO : 813 630 5554 4723 OAK FAIR BLVD. SE DECISION MADE: 21-OCT-10 TAMPA FL 33610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: T2 XVBR 1.5 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K100976(TRADITIONAL)
ATTN: THERESA LEISTER PHONE NO : 901 396 3133 1800 PYRAMID PLACE SE DECISION MADE: 21-OCT-10 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: URGENT PC STIMULATOR; URGENT PC LEAD SET UROPLASTY, INC. 510(k) NO: K101847(TRADITIONAL)
ATTN: MICHAEL MORRELL PHONE NO : 952 426 6141 5420 FELTL RD. SE DECISION MADE: 21-OCT-10 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) TANGSHAN KANGYUAN GLOVE CO., LTD. 510(k) NO: K102569(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 RM 1606 BLDG. 1. JIANXING YUAN NO.SE DECISION MADE: 21-OCT-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) TANGSHAN KANGJIE GLOVE CO., LTD. 510(k) NO: K102570(TRADITIONAL)
ATTN: CHU XIZOAN PHONE NO : 861 082 387441 JIANXIANG YUAN NO. 209 BEI SI HUANSE DECISION MADE: 21-OCT-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO LNCS/M-LNCS OXIMETRY SENSORS MASIMO CORPORATION 510(k) NO: K101896(SPECIAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7258 40 PARKER SE DECISION MADE: 21-OCT-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL ARTHROCARE CORP. 510(k) NO: K102262(TRADITIONAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408 736 0224 680 VAQUEROS AVE. SE DECISION MADE: 21-OCT-10 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES SHIJIAZHUANG HYLAND PLASTIC CO., L510(k) NO: K102611(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 ROOM 1606 BLDG.1. JIANXIANG YUAN NSE DECISION MADE: 21-OCT-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPRESS BALLOON DEVICE ENTELLUS MEDICAL, INC. 510(k) NO: K102003(TRADITIONAL)
ATTN: KAREN PETERSON PHONE NO : 763 463 7066 6705 WEDGWOOD COURT NORTH SE DECISION MADE: 22-OCT-10 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANGUARD 360 REVISION KNEE SYSTEM BIOMET, INC. 510(k) NO: K093293(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574 267 6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 22-OCT-10 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTACENTER/EXPEDITION, MODEL SAF-430 SAFARI DENTAL, INC. 510(k) NO: K100212(TRADITIONAL)
ATTN: ANDRE MATHIEU PHONE NO : 450 433 5754 94 D ENTERPRISES BOUL. SE DECISION MADE: 22-OCT-10 BOISBRIAND, QUEBEC CA J7G 2T3 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 NEUWAVE MEDICAL, INC 510(k) NO: K100744(TRADITIONAL)
ATTN: DANIEL KOSEDNAR PHONE NO : 608 512 1592 3529 ANDERSON STREET SE DECISION MADE: 22-OCT-10 MADISON WI 53704 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S DRFP LTD 510(k) NO: K100248(TRADITIONAL)
ATTN: DAGMAR MAESER PHONE NO : 312 042 89591 AMSTEL 320-I SE DECISION MADE: 22-OCT-10 AMSTERDAM NL 1017 AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 INNOCHIPS TECHNOLOGY CO., LTD. 510(k) NO: K100660(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 714 523 1592 49 CANDLEWOOD WAY SE DECISION MADE: 22-OCT-10 BUENA PARK CA 90621 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER SPINOUS PROCESS FUSION PLATE PIONEER SURGICAL TECHNOLOGY 510(k) NO: K101525(TRADITIONAL)
ATTN: BARRY E SANDS PHONE NO : 978 363 5277 5 HEMINGWAY LANE SE DECISION MADE: 22-OCT-10 WEST NEWBURY MA 01985 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLAVICLE LOCKING PLATE SYSTEM NEWCLIP TECHNICS 510(k) NO: K100944(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 22-OCT-10 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM NUVON, INC. 510(k) NO: K102135(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH STREET NW SE DECISION MADE: 22-OCT-10 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KYPHON ANCHOR FACET SCREW SYSTEM MEDTRONIC SPINE LLC. 510(k) NO: K101765(TRADITIONAL) ATTN: ERICA HOFFMAN PHONE NO : 408 548 5411 1221 CROSSMAN AVE. SE DECISION MADE: 22-OCT-10 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: M5 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K102991(TRADITIONAL)
ATTN: ZHAI PEI PHONE NO : 867 552 6582551 KEJI 12TH RD SOUTH HI-TECH INDUSTRSE DECISION MADE: 22-OCT-10 NANSHAN,SHENZHEN, GUANGDONG CH 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BLO2X OXYGEN BLOCKER PASCAL CO., INC. 510(k) NO: K102526(TRADITIONAL)
ATTN: VINCENT M TENTARELLI PHONE NO : 425 827 4694 2929 N.E. NORTHUP WAY SE DECISION MADE: 22-OCT-10 BELLEVUE WA 98004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM CONTROL-X MEDICAL, INC. 510(k) NO: K102680(TRADITIONAL) ATTN: LASZLO ADROVITZ PHONE NO : 614 777 9729 1755 ATLAS ST. SE DECISION MADE: 22-OCT-10 COLUMBUS OH 43228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KANEKA PHARMA AMERICA XPRESS-WAY RX KANEKA PHARMA AMERICA LLC 510(k) NO: K101839(TRADITIONAL)
ATTN: RAYMOND KELLY PHONE NO : 603 880 1433 5 WENTWORTH DRIVE SE DECISION MADE: 22-OCT-10 HUDSON NH 03051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM VATECH CO., LTD. 510(k) NO: K102124(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 832 623 2099 333 MEADOWLANDS PARKWAY, #303 SE DECISION MADE: 22-OCT-10 SECAUCUS NJ 07094 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON MEDTRONIC IRELAND 510(k) NO: K103095(TRADITIONAL)
ATTN: GERARDINE FINN PHONE NO : 707 566 1548 3576 UNOCAL PLACE SE DECISION MADE: 22-OCT-10 SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIRONA CAD/CAM SYSTEM SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K100152(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : 496 251 160 FABRIKSTRASSE 31 SE DECISION MADE: 22-OCT-10 BENSHEIM GM D-64625 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSEI X ROBOTIC CATHETER SYSTEM HANSEN MEDICAL, INC. 510(k) NO: K102168(SPECIAL)
ATTN: KATE WHITIN PHONE NO : 650 404 5800 800 EAST MIDDLEFIELD ROAD SE DECISION MADE: 22-OCT-10 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE NXSTAGE MEDICAL, INC. 510(k) NO: K093069(TRADITIONAL)
ATTN: MICHAEL DOYLE PHONE NO : 978 687 4746 439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 23-OCT-10 LAWRENCE MA 01843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITI CYP2C19 ASSAY AUTOGENOMICS, INCORPORATED 510(k) NO: K101683(ABBREVIATED)
ATTN: EVELYN G LOPEZ PHONE NO : 760 477 2248 2980 SCOTT STREET SE DECISION MADE: 25-OCT-10 VISTA CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM NEOS SURGERY S.L. 510(k) NO: K101235(TRADITIONAL)
ATTN: MARCOS VELEZ-DURAN PHONE NO : 703 562 9800 901 KING STREET SUITE 200 SE DECISION MADE: 25-OCT-10 ALEXANDRIA VA 22314 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRULIGHT 5520 AND TRULIGHT 5320 TRUMPF KREUZER MEDIZIN SYSTEME GMB510(k) NO: K102758(TRADITIONAL)
ATTN: LINDSEY RONNENBERG PHONE NO : 843 474 9359 1046 LEGRAND BOULEVARD SE DECISION MADE: 26-OCT-10 CHARLESTON SC 29492 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 BECKMAN COULTER CELLULAR 510(k) NO: K100489(TRADITIONAL)
ATTN: JEANNE ROSCOE PHONE NO : 305 380 2953 11800 SW 147 AVENUE MS 31 BO6 SE DECISION MADE: 26-OCT-10 MIAMI FL 33196 2500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOCONDUCT STEINER LABORATORIES DIV OF STEINE510(k) NO: K101718(TRADITIONAL)
ATTN: GREGORY G STEINER PHONE NO : 808 689 1710 590 FARRINGTON HWY., #524 SUITE 13SE DECISION MADE: 26-OCT-10 KAPOLEI HI 96707 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS WITT BIOMEDICAL CORP 510(k) NO: K101571(TRADITIONAL)
ATTN: JAMES LUKER PHONE NO : 321 253 5693 305 NORTH DR. SE DECISION MADE: 26-OCT-10 MELBOURNE FL 32934 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSC KERR CORPORATION 510(k) NO: K101756(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 26-OCT-10 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHTIP DISPOSABLE ISFET CATHETER E-CATH CO., LTD 510(k) NO: K102801(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303 463 0900 13605 WEST 7TH AVENUE SE DECISION MADE: 26-OCT-10 GOLDEN CO 80401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA EDWARDS LIFESCIENCES, LLC. 510(k) NO: K102420(SPECIAL)
ATTN: DANNETTE CROOMS PHONE NO : 801 565 6209 12050 LONE PEAK PKWY SE DECISION MADE: 26-OCT-10 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-LEAD TRIALING CABLE MODEL 355531 MEDTRONIC INC. 510(k) NO: K102523(SPECIAL) ATTN: TRISHIA DWYER PHONE NO : 763 526 3994 7000 CENTRAL AVENUE NE SE DECISION MADE: 26-OCT-10 MINNEAPOLIS MN 55432 3576 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECO-S VERICOM CO., LTD. 510(k) NO: K103121(TRADITIONAL)
ATTN: MYUNG-HWAN OH PHONE NO : 823 144 12881 #606,5TH DONGYOUNG VENTURESTEL 199SE DECISION MADE: 26-OCT-10 ANYANG-SI, GYEONGGI-DO KS 430-8510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LIGHT CURE RETAINER RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K101951(TRADITIONAL)
ATTN: PAULA WENDLAND PHONE NO : 630 773 4009 1540 WEST THORNDALE AVE. SE DECISION MADE: 26-OCT-10 ITASCA IL 60143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER PATIENT SPECIFIC POLYMER IMPLANT HOWMEDICA OSTEONICS CORP DBA STRYK510(k) NO: K103010(SPECIAL)
ATTN: STEPHANIE FITTS PHONE NO : 201 831 5405 325 CORPORATE DRIVE SE DECISION MADE: 26-OCT-10 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUGEASE VASCULAR AUGMENTATION DEVICE AUGDVT LLC 510(k) NO: K101355(TRADITIONAL)
ATTN: E. J. SMITH PHONE NO : 410 451 0639 1468 HARWELL AVE SE DECISION MADE: 26-OCT-10 CROFTON MD 21114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELEKTA NEUROMAG WITH MAXFILTER ELEKTA NEUROMAG OY 510(k) NO: K091393(TRADITIONAL) ATTN: DANIEL KAMM PHONE NO : 847 374 8854 8726 FERRARA CT. SE DECISION MADE: 26-OCT-10 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 24" WIDEN WHEELCHAIR (JY/CT-H28), 18" RECLINING WHEELCHAIR (JY-260), 18" LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18" ALUMIN FOSHAN SHUNDE JAEYONG HARDWARE CO.510(k) NO: K102110(TRADITIONAL)
ATTN: KEVIN WALLS, RAC PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 26-OCT-10 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 BIOIMAGENE, INC. 510(k) NO: K092333(TRADITIONAL)
ATTN: INDU P LAKSHMAN PHONE NO : 408 207 4242 919 HERMOSA CT. SE DECISION MADE: 27-OCT-10 SUNNYVALE CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORGENTEC RHEUMATOID FACTOR EIA ORGENTEC DIAGNOSTIKA GMBH 510(k) NO: K100499(TRADITIONAL)
ATTN: GARY LEHNUS PHONE NO : 570 620 0198 150 CHERRY LANE RD. SE DECISION MADE: 27-OCT-10 EAST STROUDSBURG PA 18301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FM-02 BONE GRAFT SUBSTITUTE ORTHOVITA, INC. 510(k) NO: K102545(SPECIAL)
ATTN: DEBORAH L JACKSON PHONE NO : 610 407 5210 45 GREAT VALLEY PKWY. SE DECISION MADE: 27-OCT-10 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOVASCULAR LAER VEIN SYSTEM KIT BIOLITEC, INC. 510(k) NO: K101712(TRADITIONAL)
ATTN: HARRY HAYES PHONE NO : 413 250 0779 1349 MAIN ROAD SE DECISION MADE: 27-OCT-10 GRANVILLE MA 01034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI JYOTI CERAMIC INDUSTRIES PRIVATE L510(k) NO: K102538(TRADITIONAL)
ATTN: RAJU MERANI PHONE NO : 915 232 350120 C-21, NICE, SATPUR SE DECISION MADE: 27-OCT-10 NASHIK, MAHARASHTRA IN 422007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K102901(SPECIAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330 425 1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 27-OCT-10 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTERVUE DIGITAL RETINOGRAPHY SYSTEM CENTERVUE SPA 510(k) NO: K101935(TRADITIONAL)
ATTN: ROGER GRAY PHONE NO : 393 201 167103 PIAZZA ALBANIA 10 SE DECISION MADE: 27-OCT-10 ROME IT 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLLEXA INNOCOLL PHARMACEUTICALS 510(k) NO: K100574(TRADITIONAL)
ATTN: AARON WYSE PHONE NO : 353 090 66091 DUBLIN ROAD SE DECISION MADE: 28-OCT-10 ATHLONE, CO. WESTMEATH EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: METRO SOFT METRO OPTICS OF AUSTIN, INC. 510(k) NO: K100244(TRADITIONAL)
ATTN: MARTIN DAISING PHONE NO : 970 243 5490 806 KIMBALL AVENUE SE DECISION MADE: 28-OCT-10 GRAND JUNCTION CO 81501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CVUE ADVANCED DEFINITIVE UNILENS CORP., USA 510(k) NO: K100456(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970 243 5490 806 KIMBALL AVENUE SE DECISION MADE: 28-OCT-10 GRAND JUNCTION CO 81501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXFIN MODEL 2 BMEYE B.V. 510(k) NO: K101123(TRADITIONAL)
ATTN: WILLIAM F GREENROSE PHONE NO : 603 369 3550 220 RIVER ROAD SE DECISION MADE: 28-OCT-10 CLAREMONT NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENESIS IMPLANT SYSTEM KEYSTONE DENTAL 510(k) NO: K101545(ABBREVIATED)
ATTN: JOHN CAPONE PHONE NO : 781 328 3300 144 MIDDLESEX TURNPIKE SE DECISION MADE: 28-OCT-10 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEFINITIVE, FLEXLENS - SILICONE HYDROGEL X-CEL CONTACTS, INC. 510(k) NO: K100443(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970 243 5490 806 KIMBALL AVENUE SE DECISION MADE: 28-OCT-10 GRAND JUNCTION CO 81501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER EDAN INSTRUMENTS, INC. 510(k) NO: K102138(TRADITIONAL)
ATTN: LIU YONGYING PHONE NO : 867 552 26899197 3/F-B, NANSHAN MEDICAL EQUIPMENT PSE DECISION MADE: 28-OCT-10 SHENZHEN CH 518067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPEEDFIX SUTURE SYSTEM ARTHROCARE CORP. 510(k) NO: K101437(SPECIAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949 585 2406 680 VAQUEROS AVE. SE DECISION MADE: 29-OCT-10 SUNNYVALE CA 94085 3523 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER INTERSURGICAL, INC. 510(k) NO: K092451(TRADITIONAL) ATTN: MICHAEL ZALEWSKI PHONE NO : 315 451 2900 417 ELECTRONICS PKWY. SE DECISION MADE: 29-OCT-10 LIVERPOOL NY 13088 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS NEMOTO KYORINDO CO., LTD. 510(k) NO: K092896(TRADITIONAL)
ATTN: JIM KNIPFER PHONE NO : 81 48 2503255 2-12-4 AOKI SE DECISION MADE: 29-OCT-10 KAWAGUCHI-SHI, SAITAMA JA 332-0510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS BIO-RAD 510(k) NO: K100589(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978 927 3808 180 CABOT STREET SE DECISION MADE: 29-OCT-10 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL ARK DIAGNOSTICS,INC 510(k) NO: K101305(TRADITIONAL)
ATTN: JOHNNY VALDEZ PHONE NO : 408 747 0706 1190 BORDEAUX DRIVE SE DECISION MADE: 29-OCT-10 SUNNYVALE CA 94089 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FDR IMAGE STITCHING OPTION FUJIFILM MEDICAL SYSTEM U.S.A., IN510(k) NO: K101686(SPECIAL) ATTN: DEBBIE PEACOCK PHONE NO : 203 602 3774 419 WEST AVE. SE DECISION MADE: 29-OCT-10 STAMFORD CT 06902 6300 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TI-CORE FLOW ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K101504(TRADITIONAL)
ATTN: JEFFREY WAN PHONE NO : 201 487 9090 89 LEUNING STREET SUITE 8 SE DECISION MADE: 29-OCT-10 SOUTH HACKENSACK NJ 07606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULACCESS MODEL 1.0 FULCRUM MEDICAL, INC 510(k) NO: K101707(TRADITIONAL)
ATTN: SCOTT BRAME PHONE NO : 800 515 9132 17209 CHESTERFIELD AIRPORT ROA SE DECISION MADE: 29-OCT-10 CHESTERFIELD MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLADEVIEW ACCOGENT LLC 510(k) NO: K101042(TRADITIONAL) ATTN: TRISTAN TICE PHONE NO : 917 513 7632 644 NORTH LAKE WAY SE DECISION MADE: 29-OCT-10 PALM BEACH FL 33480 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000 WMI ENTERPRISES LLC 510(k) NO: K101035(TRADITIONAL) ATTN: MIKE WILFORD PHONE NO : 888 253 2555 1017 W. WASHINGTON, 2J SE DECISION MADE: 29-OCT-10 CHICAGO IL 60607 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARROWHEAD FIXATION DEVICE ARROW PRODUCTS, INC. 510(k) NO: K100926(TRADITIONAL)
ATTN: SCOTT R ROMAN PHONE NO : 678 519 2159 2593 LAKE ERMA DRIVE SE DECISION MADE: 29-OCT-10 HAMPTON GA 30228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE NOVOCOL INC. DBA SEPTODONT AND CON510(k) NO: K101540(ABBREVIATED)
ATTN: STEVE RUDOLPH PHONE NO : 303 665 7535 416 S. TAYLOR AVE SE DECISION MADE: 29-OCT-10 LOUISVILLE CO 80027 510(k) STATEMENT DEVICE: ALL-BOUND 3 BISCO, INC. 510(k) NO: K102844(SPECIAL)
ATTN: MICHELLE SCHILTZ-TAING PHONE NO : 847 534 6146 1100 WEST IRVING PARK RD. SE DECISION MADE: 29-OCT-10 SCHAUMBURG IL 60193 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIGERPAW SYSTEM LAAX, INC. 510(k) NO: K101961(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 925 254 5228 8 SNOWBERRY COURT SE DECISION MADE: 29-OCT-10 ORINDA CA 94563 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) DO CO., LTD. 510(k) NO: K102575(TRADITIONAL)
ATTN: PRISCILLA CHUNG PHONE NO : 714 844 2612 2341 W. CRESCENT AVE #3 SE DECISION MADE: 29-OCT-10 ANAHEIM CA 92801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3M INTEGRATED CYCLER (110V) & (220V) FOCUS DIAGNOSTICS, INC. 510(k) NO: K102314(TRADITIONAL)
ATTN: TARA VIVIANI PHONE NO : 714 822 2115 11331 VALLEY VIEW ST SE DECISION MADE: 29-OCT-10 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORT RUBBER GLOVES IND.SDN.BHD. COMFORT RUBBER GLOVES INDUSTRIES S510(k) NO: K101917(TRADITIONAL)
ATTN: TAN KENG BENG PHONE NO : 006 058 472888 LOT 821, JALAN MATANG SE DECISION MADE: 29-OCT-10 TAIPING, PERAK DARUL RIDZUAN MY510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX-D 300 AGFA HEALTHCARE N.V. 510(k) NO: K103050(TRADITIONAL)
ATTN: PHIL CUSCUNA PHONE NO : 416 240 7317 10 S ACADEMY STREET SE DECISION MADE: 29-OCT-10 GREENVILLE SC 29601 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIGITAL RETINAL CAMERA CANON, INC.-MEDICAL EQUIPMENT GROU510(k) NO: K102013(SPECIAL)
ATTN: KOJI KUBO PHONE NO : 814 254 81253 3F 2-17-6 AKEBONO-CHO SE DECISION MADE: 29-OCT-10 TACHIKAWA-SHI, TOKYO JA 190-001510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRANDTEC VOCO GMBH 510(k) NO: K102347(TRADITIONAL)
ATTN: T GERKENSMEIER PHONE NO : 494 721 719200 ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 29-OCT-10 CUXHAVEN GM D-27472 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE) EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K102655(TRADITIONAL) ATTN: KATHY LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 29-OCT-10 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY PINNACLE ALTRX ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K102423(SPECIAL)
ATTN: BRANDON HIPSHER PHONE NO : 574 371 7465 700 ORTHOPAEDIC DR. SE DECISION MADE: 29-OCT-10 WARSAW IN 46581 0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) MEDIGUIDE, LTD. 510(k) NO: K102905(SPECIAL) ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 COLUMBIA SQUARE 555 THIRTEENTH STRSE DECISION MADE: 29-OCT-10 WASHINGTON DC 20004 1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD 510(k) NO: K102906(SPECIAL) ATTN: LIU YI PHONE NO : 862 260 526161 NO 3, JINPING STREET YA AN RD NANSE DECISION MADE: 29-OCT-10 TIANJIN CH 300190 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 252 TOTAL WITH SUMMARIES 237 TOTAL WITH STATEMENTS 15
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