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Medical Devices
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October 2009 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD October 2009 DEVICE: WATERLASE MD BIOLASE TECHNOLOGY, INC. 510(k) NO: K083927(TRADITIONAL)
ATTN: IOANNA RIZOU PHONE NO : 949 226 8144 4 CROMWELL SE DECISION MADE: 01-OCT-09 IRVINE CA 92618 1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CARTO RMT EP NAVIGATION SYSTEM V8 BIOSENSE WEBSTER, INC. 510(k) NO: K091789(TRADITIONAL)
ATTN: DIANA THORSON PHONE NO : 909 839 8604 3333 DIAMOND CANYON RD. SE DECISION MADE: 01-OCT-09 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICCOLO MAGNESIUM TEST SYSTEM ABAXIS, INC. 510(k) NO: K091910(SPECIAL)
ATTN: DENNIS M BLEILE PHONE NO : 510 675 6515 3240 WHIPPLE RD. SE DECISION MADE: 01-OCT-09 UNION CITY CA 94587 510(k) STATEMENT DEVICE: DYNESYS TOP-LOADING SPINAL SYSTEM ZIMMER SPINE, INC 510(k) NO: K092234(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952 830 6205 7375 BUSH LAKE RD. SE DECISION MADE: 01-OCT-09 MINNEAPOLIS MN 55439 2027 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEAMFREE APEX DENTAL MATERIALS, INC. 510(k) NO: K092539(TRADITIONAL)
ATTN: CHRIS KULTON PHONE NO : 877 273 9123 330 TELSER ROAD SE DECISION MADE: 01-OCT-09 LAKE ZURICH IL 60047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUARDIAN II HEMOSTASIS VALVE ZERUSA LIMITED 510(k) NO: K092711(SPECIAL)
ATTN: LIAM MULLOY PHONE NO : 353 91 863060 219-220 BUSINESS INNOVATION CR NUISE DECISION MADE: 01-OCT-09 GALWAY EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVISION DATA MANAGEMENT SOFTWARE NONIN MEDICAL, INC. 510(k) NO: K092678(SPECIAL)
ATTN: LORI M ROTH PHONE NO : 763 577 3093 13700 1ST AVE. NORTH SE DECISION MADE: 01-OCT-09 PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) CUTERA, INC. 510(k) NO: K092195(SPECIAL)
ATTN: KATHY MAYNOR PHONE NO : 415 657 5586 3240 BAYSHORE BLVD SE DECISION MADE: 01-OCT-09 BRISBANE CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTOMED SMARTSCOPE, MODEL M3-1 EY1 OPTOMED OY 510(k) NO: K092056(TRADITIONAL)
ATTN: LAURA OJALA PHONE NO : 358 40 7280664 HALLITUSKATU 13-17 D 96 SE DECISION MADE: 01-OCT-09 OULU FI 90100 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT KETTENBACH GMBH & CO KG 510(k) NO: K092867(TRADITIONAL)
ATTN: MICHAELA ZINKE PHONE NO : 49 277 470558 IM HEERFELD 7 SE DECISION MADE: 01-OCT-09 ESCHENBURG GM 35713 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN MEDLINE INDUSTRIES, INC. 510(k) NO: K090568(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847 643 4785 ONE MEDLINE PL. SE DECISION MADE: 02-OCT-09 MUNDELEIN IL 60060 510(k) STATEMENT DEVICE: KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE KENSEY NASH CORP. 510(k) NO: K090919(TRADITIONAL)
ATTN: ALYSSA SCHWARTZ PHONE NO : 484 713 2100 735 PENNSYLVANIA DRIVE SE DECISION MADE: 02-OCT-09 EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EOCENE SYSTEM INFOPIA CO., LTD 510(k) NO: K090712(SPECIAL)
ATTN: MARIA F GRIFFIN PHONE NO : 704 843 1675 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 02-OCT-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K091217(TRADITIONAL)
ATTN: NANCY BENNEWITZ JOY PHONE NO : 732 661 2381 125 MAY STREET SE DECISION MADE: 02-OCT-09 EDISON NJ 08837 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROFUSE DUAL RATE INFUSER NUMIA MEDICAL TECHNOLOGY, LLC 510(k) NO: K091386(SPECIAL)
ATTN: ERIC FLACHBART PHONE NO : 802 284 4105 230 MAIN ST SE DECISION MADE: 02-OCT-09 LYNDONVILLE VT 05851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEFORTE SYSTEM BONE PLATE JEIL MEDICAL CORPORATION 510(k) NO: K091679(TRADITIONAL)
ATTN: SHIN KUK YOO PHONE NO : 714 313 7442 215 S. STATE STREET STE: 100B SE DECISION MADE: 02-OCT-09 SALT LAKE CITY UT 84111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K092676(SPECIAL)
ATTN: LILA JOE PHONE NO : 901 396 3133 1800 PYRAMID PL. SE DECISION MADE: 02-OCT-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGY CANNULATED SCREW SYSTEM SYNERGY SURGICAL TECHNOLOGIES, LLC510(k) NO: K092082(TRADITIONAL)
ATTN: KEVIN THOMAS PHONE NO : 858 792 1235 11234 EL CAMINO REAL, SUITE 200 SE DECISION MADE: 02-OCT-09 SAN DIEGO CA 92130 510(k) STATEMENT DEVICE: SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM SONOSITE,INC. 510(k) NO: K092058(TRADITIONAL)
ATTN: DAINA L GRAHAM PHONE NO : 21919 30TH DRIVE SE. SE DECISION MADE: 02-OCT-09 BOTHELL WA 98021 3904 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BAXANO NEURO CHECK DEVICE BAXANO, INC. 510(k) NO: K092729(SPECIAL)
ATTN: CINDY DOMECUS PHONE NO : 650 343 4813 1171 BARROILHET AVENUE SE DECISION MADE: 02-OCT-09 HILLSBOROUGH CA 94010 6577 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPER-FINE PEN NEEDLE STAT MEDICAL DEVICES, INC. 510(k) NO: K092016(SPECIAL)
ATTN: MARY L JEAN PHONE NO : 305 949 7828 2056 NE 153RD ST. SE DECISION MADE: 02-OCT-09 NORTH MIAMI BEACH FL 33162 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 ENTOMED AB 510(k) NO: K092111(TRADITIONAL)
ATTN: CHARLOTTE MATTISSON PHONE NO : 464 021 0090 BARIUMGATAN 29 SE DECISION MADE: 02-OCT-09 MALMO SW 213 64 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIA-PACK RBC FOLATE TOSOH BIOSCIENCE, INC. 510(k) NO: K091332(TRADITIONAL)
ATTN: CHARLES P GILL PHONE NO : 614 317 1909 3600 GANTZ ROAD SE DECISION MADE: 02-OCT-09 GROVE CITY OH 43123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STELLAR FIDUCIAL MARKER, MODEL GFMIA STELLAR MEDICAL LLC. 510(k) NO: K092041(TRADITIONAL)
ATTN: BENJAMIN ROEDELL PHONE NO : 727 808 9680 12738 BUCKHORN DRIVE SE DECISION MADE: 02-OCT-09 HUDSON FL 34669 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL SENTINELLA 102 GENERAL EQUIPMENT FOR MEDICAL IMAG510(k) NO: K092471(TRADITIONAL)
ATTN: SEVERINE MOINE PHONE NO : 34 96 3722472 CAMINO DE VERA S/N EDIFICIO 9B SE DECISION MADE: 02-OCT-09 VALENCIA SP 46022 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EASYCARE TX, TX LINK RESMED LTD. 510(k) NO: K092026(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 02-OCT-09 BELLA VISTA CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. 510(k) NO: K092037(TRADITIONAL)
ATTN: CINDY GREEN PHONE NO : 425 765 9509 21031 SE 202ND STREET SE DECISION MADE: 02-OCT-09 RENTON WA 98058 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOSUCCESS, MODEL C-SUC-01, C-SUC-02, C-DTS-02, C-DTS-03, C-GTS-13. C-CA-23 NEW MEDICAL TECHNOLOGIES GMBH 510(k) NO: K091721(TRADITIONAL)
ATTN: VINCE D'ALESSANDRO PHONE NO : 610 239 6015 1710 ROMANO DRIVE SE DECISION MADE: 02-OCT-09 PLYMOUTH MEETING PA 19462 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADDPLUS ULRICH GMBH & CO. KG 510(k) NO: K090841(TRADITIONAL)
ATTN: MERLE SYMES PHONE NO : 636 519 0268 754 SPIRIT 40 PARK DRIVE SE DECISION MADE: 05-OCT-09 CHESTERFIELD MO 63005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BTI DENTAL IMPLANT TINY 2.5-3.0 B.T.I. BIOTECHNOLOGY INSTITUTE, S.510(k) NO: K092112(TRADITIONAL)
ATTN: ALFREDO GOMEZ PHONE NO : 349 452 97030 LEONARDO DA VINCI 14 B SE DECISION MADE: 06-OCT-09 MINANO(ALAVA) SP 01510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLEXICARE BREATHING FILTERS FLEXICARE MEDICAL LTD. 510(k) NO: K092218(TRADITIONAL)
ATTN: DAVID MOYNHAM PHONE NO : 44 144 3474647 CYNON VALLEY BUSINESS PARK MOUNTAISE DECISION MADE: 06-OCT-09 MID GLAMORGAN UK CF45 4ER 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: BEGO SEMADOS S-LINE BEGO IMPLANT SYSTEMS GMBH & CO. KG510(k) NO: K090716(TRADITIONAL)
ATTN: MARTIN ELLERHORST PHONE NO : 49 412 2028264 WILHELM HERBST STRASSE 1 SE DECISION MADE: 06-OCT-09 BREMEN GM 28359 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHOTEX30 DIODE LASER SERIES: 980, 810, 940 BIOTEX, INC. 510(k) NO: K092197(TRADITIONAL)
ATTN: ASHOK GOWDA PHONE NO : 713 741 0111 8058 EL RIO ST. SE DECISION MADE: 06-OCT-09 HOUSTON TX 77054 4185 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OSSEOLINK DENTAL IMPLANT SYSTEM GLOBAL IMPLANT SOLUTIONS, LLC 510(k) NO: K091878(TRADITIONAL)
ATTN: STUART R GOLDMAN PHONE NO : 512 327 9997 1705 S. CAPITAL OF TEXAS HWY SUITESE DECISION MADE: 06-OCT-09 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERPLATE C RSB SPINE LLC. 510(k) NO: K092070(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440 729 8457 8202 SHERMAN ROAD SE DECISION MADE: 06-OCT-09 CHESTERLAND OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM NUVASIVE, INC. 510(k) NO: K092287(SPECIAL)
ATTN: SHEILA BRUSCHI PHONE NO : 858 320 4515 7475 LUSK BLVD SE DECISION MADE: 06-OCT-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELPROCERA IMPLANT BRIDGE ZIRCONIA NOBEL BIOCARE AB 510(k) NO: K091907(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PKWY. SE DECISION MADE: 06-OCT-09 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) ZI BO YUXIANG GLOVES CO., LTD. 510(k) NO: K092516(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 1 JIAN XIANG YUAN # 209 BEI SI HUASE DECISION MADE: 07-OCT-09 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OR-LIGHT YPERION TECHNOLOGY 510(k) NO: K090724(TRADITIONAL)
ATTN: PASCAL DANET PHONE NO : 331 568 91040 2 RUE BEETHOVEN SE DECISION MADE: 07-OCT-09 PARIS FR 75016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TAKE 1 KERR CORP. 510(k) NO: K091613(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714 516 7602 1717 W. COLLINS AVENUE SE DECISION MADE: 07-OCT-09 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO GENORAY CO., LTD. 510(k) NO: K091918(TRADITIONAL)
ATTN: SHIN KUK YOO PHONE NO : 714 313 7442 215 S. STATE STREET, STE 100B SE DECISION MADE: 07-OCT-09 SALT LAKE CITY UT 84111 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISPIRA RESUSCITATION UNIT NEOFORCE GROUP, INC. 510(k) NO: K092085(TRADITIONAL)
ATTN: MONICA FERRANTE PHONE NO : 215 672 6800 35 COMMERCE DR. SE DECISION MADE: 07-OCT-09 IVYLAND PA 18974 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-PROX ENDOSCOPIC GRASPER, MODEL 205333 USGI MEDICAL 510(k) NO: K093018(SPECIAL)
ATTN: MARY L MOONEY PHONE NO : 949 369 3890 1140 CALLE CORDILLERA SE DECISION MADE: 07-OCT-09 SAN CLEMENTE CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052 LEVITRONIX LLC. 510(k) NO: K090051(TRADITIONAL)
ATTN: SUSAN HAMANN PHONE NO : 781 466 6553 45 FIRST AVE. SE DECISION MADE: 08-OCT-09 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MTD 4000 METTLER ELECTRONICS CORP. 510(k) NO: K091540(ABBREVIATED)
ATTN: ROBERT FLEMING PHONE NO : 714 533 2221 1333 SOUTH CLAUDINA ST. SE DECISION MADE: 08-OCT-09 ANAHEIM CA 92805 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER ONSET MEDICAL CORPORATION 510(k) NO: K092014(TRADITIONAL)
ATTN: PHONE NO : 13900 ALTON PARKWAY, SUITE 120 SE DECISION MADE: 08-OCT-09 IRVINE CA 92618 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: PMD VIEWER SPENCER TECHNOLOGIES 510(k) NO: K092204(TRADITIONAL)
ATTN: TONY WILLIAMS PHONE NO : 206 329 7220 701 16TH AVE. SE DECISION MADE: 08-OCT-09 SEATTLE WA 98122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K092763(SPECIAL)
ATTN: JENNY HSIEH PHONE NO : 886 229 282112 1FL, NO.16, LANE 454 JUNGJENG RD. SE DECISION MADE: 08-OCT-09 YUNGHE CITY, TAIPEI COUNTY TW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BODY COMPOSITION ANALYZER, MODEL: IOI 353 JAWON MEDICAL CO., LTD. 510(k) NO: K092431(SPECIAL)
ATTN: H L JUNG PHONE NO : 822 626 49001 ROOM 431, LIFE OFFICETEL, 61-3 YOISE DECISION MADE: 08-OCT-09 SEOUL, KOREA KS 150-731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENGAGE/ENGAGE TR ST. JUDE MEDICAL 510(k) NO: K092575(TRADITIONAL)
ATTN: LINH PHAM PHONE NO : 14901 DEVEAU PLACE SE DECISION MADE: 08-OCT-09 MINNETONKA MN 55345 2126 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO FMRI HARDWARE SYSTEM NORDICNEUROLAB 510(k) NO: K092253(SPECIAL)
ATTN: CHANDANA GURUNG BHANDARI PHONE NO : 47 95 203787 MOLLENDALSVEIEN 65C SE DECISION MADE: 08-OCT-09 BERGEN NO N-5009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE EDWARDS LIFESCIENCES, LLC. 510(k) NO: K092509(TRADITIONAL)
ATTN: KAREN JONES PHONE NO : 801 565 6231 6864 SOUTH 300 WEST SE DECISION MADE: 08-OCT-09 MIDVALE UT 84047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSELECTRON HDR V2, MODEL 105.999 NUCLETRON CORP. 510(k) NO: K092804(SPECIAL)
ATTN: ELAINA COLBY PHONE NO : 410 545 2164 8671 ROBERT FULTON DRIVE SE DECISION MADE: 08-OCT-09 COLUMBIA MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOFFMAN XPRESS LINE EXTENSION HOWMEDICA OSTEONICS CORP. 510(k) NO: K092834(SPECIAL)
ATTN: MELISSA A MATARESE PHONE NO : 201 831 5116 325 CORPORATE DRIVE SE DECISION MADE: 08-OCT-09 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMAGEGRID RADIOLOGY VIEWER SYSTEM CANDELIS, INC. 510(k) NO: K092949(TRADITIONAL)
ATTN: CARL ALETTO PHONE NO : 940 300 8601 1600 MANCHESTER WAY SE DECISION MADE: 08-OCT-09 CORINTH TX 76210 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAXIFLO, TAPERFLO VASCUTEK LTD. 510(k) NO: K092863(SPECIAL)
ATTN: KAREN KELSO PHONE NO : 141 812 5555 NEWMAINS AVE. INCHINNAN INDUSTRIALSE DECISION MADE: 08-OCT-09 RENFREWSHIRE, GLASGOW UK PA4 9R510(k) STATEMENT DEVICE: REMOTE INFRARED THERMOMETER, MODEL RC002 RYCOM ELECTRON TECHNOLOGY LIMITED 510(k) NO: K090361(ABBREVIATED)
ATTN: DIANA HONG PHONE NO : 86 21 64264467 SUITE 8D, NO. 19, LANE 999 ZHONGSHSE DECISION MADE: 08-OCT-09 SHANGHAI CH 200030 510(k) STATEMENT DEVICE: SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS SPS MEDICAL SUPPLY CORP. 510(k) NO: K090650(TRADITIONAL)
ATTN: GARY J SOCOLA PHONE NO : 585 359 0130 6789 WEST HENRIETTA RD. SE DECISION MADE: 09-OCT-09 RUSH NY 14543 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAINBOW BLOCK GENOSS CO., LTD. 510(k) NO: K092513(ABBREVIATED)
ATTN: EUNKYUNG SON PHONE NO : 714 895 7278 11075 KNOTT AVE., SUITE A SE DECISION MADE: 09-OCT-09 CYPRESS CA 90630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3 WAY SILICONE FOLEY BALLOON CATHETER COOK UROLOGICAL, INC. 510(k) NO: K091767(TRADITIONAL)
ATTN: BRENDA DAVIS PHONE NO : 812 829 4891 1100 WEST MORGAN ST. SE DECISION MADE: 09-OCT-09 SPENCER IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL EXTRAORAL SOURCE X-RAY SYSTEM (ESX) VATECH CO., LTD. 510(k) NO: K092103(TRADITIONAL)
ATTN: VINCENT LEE PHONE NO : 281 598 8139 256 NORTH SAM HOUSTON PKWY E. SUITSE DECISION MADE: 09-OCT-09 HOUSTON TX 77060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) ZHANGJIANGANG ALL FINE RUBBER-PLAS510(k) NO: K092109(TRADITIONAL)
ATTN: PHONE NO : RM 1606, BLDG 1, JIAN XIANG YUAN NSE DECISION MADE: 09-OCT-09 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL 6000 TWO PARAMETER BEDSIDE MONITOR IVY BIOMEDICAL SYSTEMS, INC. 510(k) NO: K091787(TRADITIONAL)
ATTN: JENNIFER LAINE PHONE NO : 203 481 4183 11 BUSINESS PARK DR. SE DECISION MADE: 09-OCT-09 BRANFORD CT 06405 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIN-NEUS STEREOTACTIC SURGERY TREATMENT PLANNING SYSTEM NUCLEMED S.A. 510(k) NO: K090190(TRADITIONAL)
ATTN: RAYMOND KELLY PHONE NO : 603 595 0095 56B SHADOWBROOK DR. SE DECISION MADE: 09-OCT-09 HUDSON NH 03051 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY USA, INC. 510(k) NO: K090653(TRADITIONAL)
ATTN: HAMID IDRISSI PHONE NO : 952 646 3171 5182 WEST 76TH ST. SE DECISION MADE: 09-OCT-09 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT ORTHO DEVELOPMENT CORP. 510(k) NO: K090705(TRADITIONAL)
ATTN: JOHANNE YOUNG PHONE NO : 801 619 3450 12187 SOUTH BUSINESS PARK DR. SE DECISION MADE: 09-OCT-09 DRAPER UT 84020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) INSTRUMENTATION LABORATORY CO. 510(k) NO: K090563(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781 861 4467 526 RT. 303 SE DECISION MADE: 09-OCT-09 ORANGEBURG NY 10962 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILK BLACK BRAIDED SURGICAL SUTURES, NYLON MONOFILAMENT BLUE AND BLACK SURGICAL SUTURES SUPPLIDORES UNIDOS INTERNACIONALES510(k) NO: K091574(ABBREVIATED)
ATTN: VICTOR PEREIRA PHONE NO : 305 401 0421 PO BOX 97-0132 SE DECISION MADE: 09-OCT-09 COCONUT CREEK FL 33067 2366 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMARTTRACK SYSTEM NEXUS6, LTD. 510(k) NO: K091803(TRADITIONAL)
ATTN: GARTH SUTHERLAND PHONE NO : 64 9 3072771 LEVEL 2, 109 COOK STREET SE DECISION MADE: 09-OCT-09 AUCKLAND NZ 1010 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L BOVIE MEDICAL 510(k) NO: K091440(TRADITIONAL)
ATTN: RICHARD KOZLOFF PHONE NO : 727 803 8513 5115 ULMERTON ROAD SE DECISION MADE: 09-OCT-09 CLEARWATER FL 33760 4004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUSSE SURGICAL DRAPES III BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K092212(SPECIAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631 435 4711 75 ARKAY DR. SE DECISION MADE: 09-OCT-09 HAUPPAUGE NY 11788 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAMINOPLASTY FIXATION SYSTEM NUVASIVE, INC. 510(k) NO: K091623(TRADITIONAL)
ATTN: HAN FAN PHONE NO : 858 909 3338 7475 LUSK BLVD SE DECISION MADE: 09-OCT-09 SAN DIEGO CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K091584(TRADITIONAL)
ATTN: SUSAN CHRISTENSEN PHONE NO : 801 208 4789 1600 WEST MERIT PKWY. SE DECISION MADE: 09-OCT-09 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, MODELS 1780, 1797 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K091216(TRADITIONAL)
ATTN: NOOR MALKI PHONE NO : 781 269 3401 2 EDGEWATER DRIVE SE DECISION MADE: 09-OCT-09 NORWOOD MA 02062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO E-WOO TECHNOLOGY 510(k) NO: K090991(TRADITIONAL)
ATTN: VINCENT LEE PHONE NO : 281 598 8110 256 NORTH SAM HOUSTON PKWY E. SUITSE DECISION MADE: 09-OCT-09 HOUSTON TX 77060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMYPOWER ALL TRACK SERIES POWER WHEELCHAIR AMYLIOR, INC. 510(k) NO: K092225(TRADITIONAL)
ATTN: ERIC DUGAS PHONE NO : 450 424 0288 1650 CHICOINE VAUDREUIL- DORIAN SE DECISION MADE: 09-OCT-09 QUEBEC CA J7V 8P2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOYAGER COMPACT IMAGING SYSTEM ARDENT SOUND, INC. 510(k) NO: K092182(TRADITIONAL)
ATTN: DEBORAH VAN GORDER PHONE NO : 33 SOUTH SYCAMORE ST. SE DECISION MADE: 09-OCT-09 MESA AZ 85202 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ELETONE CREAM FERNDALE PHARMA GROUP, INC. 510(k) NO: K092297(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 248 586 8433 780 W. 8 MILE ROAD SE DECISION MADE: 09-OCT-09 FERNDALE MI 48220 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIMPLYGO HANDS FREE BREAST PUMP EVENFLO COMPANY, INC. 510(k) NO: K092770(SPECIAL)
ATTN: AMY NEFF PHONE NO : 937 415 3300 225 BYERS RD. SE DECISION MADE: 09-OCT-09 MIAMISBURG OH 45342 510(k) STATEMENT DEVICE: BD SPINAL NEEDLE 27G BECTON DICKSON & CO. 510(k) NO: K091758(SPECIAL)
ATTN: PASQUALE AMATO PHONE NO : 201 847 4513 1 BECTON DR. MC237 SE DECISION MADE: 09-OCT-09 FRANKLIN LAKES NJ 07417 1880 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) JAWON MEDICAL CO., LTD. 510(k) NO: K092432(SPECIAL)
ATTN: H L JUNG PHONE NO : 822 626 49001 ROOM 431, LIFE OFFICETEL, 61-3 YOISE DECISION MADE: 09-OCT-09 SEOUL, KOREA KS 150-731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) NANOSPHERE, INC 510(k) NO: K092566(TRADITIONAL)
ATTN: GREGORY W SHIPP PHONE NO : 847 400 9115 4088 COMMERCIAL AVENUE SE DECISION MADE: 09-OCT-09 NORTHBROOK IL 60062 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIANALYZER XPRESS RADI MEDICAL SYSTEMS AB 510(k) NO: K092105(TRADITIONAL)
ATTN: MATS GRANLUND PHONE NO : 46 18 161000 PALMBLADSGATAN 10 SE DECISION MADE: 09-OCT-09 UPPSALA SW SE-754 50 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTWAY POWER MOBILITY SCOOTER, S12 HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K092650(TRADITIONAL)
ATTN: KE MIN JEN PHONE NO : 886 352 08829 ROC CHINESE- EUROPEAN IND. NO.58, SE DECISION MADE: 09-OCT-09 HSIN CHU CITY,,, TW HSQ TW 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IYUNNI 3ID TRI-FUNNEL GASTROSTOMY TUBE KIT SAINATH INTELLECTUAL PROPERTIES, L510(k) NO: K092049(TRADITIONAL)
ATTN: CHRISTOPHER PARADIES PHONE NO : 813 222 1190 501 E KENNEDY BLVD. SUITE 1700 SE DECISION MADE: 09-OCT-09 TAMPA FL 33602 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770 K-JUMP HEALTH CO., LTD. 510(k) NO: K092806(SPECIAL)
ATTN: JASON CHENG PHONE NO : 886 2 22991378 NO. 56, WU KUNG 5TH RD., WU KU INDSE DECISION MADE: 09-OCT-09 TAIPEI HSIEN TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR THERA-TEST LABORATORIES INC. 510(k) NO: K092757(SPECIAL)
ATTN: MARIUS TEODORESCU PHONE NO : 630 627 6069 1111 N. MAIN ST. SE DECISION MADE: 09-OCT-09 LOMBARD IL 60148 510(k) STATEMENT DEVICE: EP-WORKMATE SYSTEM, VERSION 4.2 ST. JUDE MEDICAL 510(k) NO: K092810(SPECIAL)
ATTN: TIMOTHY J KAPPERS PHONE NO : 651 756 2904 575 ROUTE 73 N BUILDING D SE DECISION MADE: 09-OCT-09 WEST BERLIN NJ 08901 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K092747(TRADITIONAL)
ATTN: MICHAEL A CHILBERT PHONE NO : 440 483 3284 595 MINER RD. SE DECISION MADE: 09-OCT-09 CLEVELAND OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: APLIO MX SSA-780A, VERSION 1.0 TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K092948(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714 730 5000 2441 MICHELLE DR SE DECISION MADE: 09-OCT-09 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CAROTID COIL 5000004901 SHANGHAI CHENGUANG MEDICAL TECHNOL510(k) NO: K092962(TRADITIONAL)
ATTN: JIE HUANG PHONE NO : 862 152 961075 BLDG 8, LANE 1199, JIDI ROAD SE DECISION MADE: 09-OCT-09 SHANGHAI CH 201107 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MAXMORESPINE TOM STICK HOOGLAND SPINE PRODUCTS GMBH 510(k) NO: K083552(ABBREVIATED)
ATTN: BORIS MIKLITZ PHONE NO : 490 892 04000283 ARABELLASTR 4 SE DECISION MADE: 09-OCT-09 MUENCHEN GM D-81925 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATLOG 2.0 ONCOLOG MEDICAL QA AB 510(k) NO: K092939(TRADITIONAL)
ATTN: JAN TORNQVIST PHONE NO : 011 461 8194565 VALLVAGEN 4B SE DECISION MADE: 09-OCT-09 UPPSALA SW SE 756-51 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES BIOSENSE WEBSTER, INC. 510(k) NO: K090017(TRADITIONAL)
ATTN: BALAKA DAS PHONE NO : 909 839 8599 3333 DIAMOND CANYON RD. SE DECISION MADE: 13-OCT-09 DIAMOND BAR CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE TPE INFUSION SET SHAN DONG WEI GAO GROUP MEDICAL PO510(k) NO: K090459(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 684973 STE.8D, ZHONGXIN ZHONGSHAN #2 ROADSE DECISION MADE: 13-OCT-09 SHAN NAN ER RD., SHANGHAI CH 20510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSAL ECG ELECTRODES, MODEL EASYRODE SUZUKEN CO., LTD. 510(k) NO: K092389(TRADITIONAL)
ATTN: KOJI KUBO PHONE NO : 81 42 5481253 3F, 2-17-6 AKEBONO-CHO SE DECISION MADE: 13-OCT-09 TACHIKAWA-SHI, TOKYO JA 190-001510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC EDWARDS LIFESCIENCES, LLC. 510(k) NO: K091709(TRADITIONAL)
ATTN: JASON SMITH PHONE NO : 949 250 2662 ONE EDWARDS WAY SE DECISION MADE: 13-OCT-09 IRVINE CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRIND GUARD ARCHTEK, INC. 510(k) NO: K090472(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972 849 5167 1705 SOUTH CAPITOL OF TEXAS HW SE DECISION MADE: 14-OCT-09 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 SOLTA MEDICAL, INC. 510(k) NO: K091420(TRADITIONAL)
ATTN: HEATHER MACFALLS PHONE NO : 510 782 2286 25881 INDUSTRIAL BLVD. SE DECISION MADE: 14-OCT-09 HAYWOOD CA 94043 2991 510(k) STATEMENT DEVICE: HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131 CONCENTRIC MEDICAL, INC. 510(k) NO: K091703(TRADITIONAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650 938 2100 301 E. EVELYN AVE. SE DECISION MADE: 14-OCT-09 MOUNTAIN VIEW CA 94041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECTROFLUIDGRAPH AKERN USA, LLC 510(k) NO: K091369(TRADITIONAL)
ATTN: KEVIN WELLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD COURT SE DECISION MADE: 14-OCT-09 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO VIDACARE CORPORATION 510(k) NO: K091140(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949 262 0411 3722 AVE. SAUSALITO SE DECISION MADE: 14-OCT-09 IRVIN CA 92606 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SONICFILL 2010 SYBRON DENTAL SPECIALTIES, INC. 510(k) NO: K091091(TRADITIONAL)
ATTN: CLAUDIA ORTIZ PHONE NO : 714 516 7981 1717 W. COLLINS AVE. SE DECISION MADE: 14-OCT-09 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RHYTHYM OF LIFE, MODEL R0901-05 RAPID RESPONSE SOLUTIONS, LLC 510(k) NO: K092408(TRADITIONAL)
ATTN: JORGE MILAN PHONE NO : 305 925 1260 601 WEST 20 STREET SE DECISION MADE: 14-OCT-09 HIALEAH FL 33010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAD 12, COLONOSCOPY ASSIST DEVICE SOFTSCOPE MEDICAL TECHNOLOGIES, IN510(k) NO: K092156(TRADITIONAL)
ATTN: BERNARD HORWATH PHONE NO : 651 481 9734 4486 TIMBERLINE CT. SE DECISION MADE: 14-OCT-09 VADNAIS HEIGHTS MN 55127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFEBRIDGE B2T, MODEL 7001 LIFEBRIDGE MEDIZINTECHNIK AG 510(k) NO: K090006(TRADITIONAL)
ATTN: KATHLEEN JOHNSON PHONE NO : 610 527 0585 1282 ROUND HILL RD. SE DECISION MADE: 15-OCT-09 BRYN MAWR PA 19010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TANDA RESTORE, MODEL PTSCS PHAROS LIFE CORPORATION 510(k) NO: K090008(TRADITIONAL)
ATTN: PHIL CUSCUNA PHONE NO : 519 651 1177 11-380 JAMIESON PKWY SE DECISION MADE: 15-OCT-09 CAMBRIDGE, ONTARIO CA N3C 4N4 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL CARTAGLOVES S.A. 510(k) NO: K091471(TRADITIONAL)
ATTN: SAM KAO PHONE NO : 714 953 5326 2700 NORTH MAIN STREET SUITE 820 SE DECISION MADE: 15-OCT-09 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STENT GRAFT BALLOON CATHETER VIA BIOMEDICAL, INC. 510(k) NO: K091624(TRADITIONAL)
ATTN: FERNANDO DI CAPRIO PHONE NO : 763 577 9936 6655 WEDGEWOOD RD, SUITE 150 SE DECISION MADE: 15-OCT-09 MAPLE GROVE MN 55311 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C-THRU SPINAL SYSTEM EBI, L.P. 510(k) NO: K092336(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PKWY. SE DECISION MADE: 15-OCT-09 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 EV3 NEUROVASCULAR 510(k) NO: K091458(TRADITIONAL)
ATTN: TOM DAUGHTERS PHONE NO : 949 231 7780 9775 TOLEDO WAY SE DECISION MADE: 15-OCT-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6 INVATEC S.P.A. 510(k) NO: K092177(TRADITIONAL)
ATTN: STEVE CAMP PHONE NO : 610 625 1402 3101 EMRICK BLVD SE DECISION MADE: 15-OCT-09 BETHLEHEM PA 18020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 MASIMO CORPORATION 510(k) NO: K092838(SPECIAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949 297 7258 40 PARKER SE DECISION MADE: 15-OCT-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DC-7 DIAGNOSTIC ULTRASOUND SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K092691(TRADITIONAL)
ATTN: SHENG HAOBIN PHONE NO : 867 558 6119549 MINDRAY BUILDING, KEJI 12TH RD SOUSE DECISION MADE: 15-OCT-09 NANSHAN,SHENZHEN, P.R. CHINA CH510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION BICON, LLC 510(k) NO: K092035(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617 390 4363 501 ARBORWAY SE DECISION MADE: 15-OCT-09 BOSTON MA 02130 510(k) STATEMENT DEVICE: THAI NIPPON MALE LATEX CONDOM THAI NIPPON RUBBER INDUSTRY CO., L510(k) NO: K081265(ABBREVIATED)
ATTN: ELI J CARTER PHONE NO : 919 544 4098 PO BOX 12139 SE DECISION MADE: 16-OCT-09 DURHAM NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN ROCHE DIAGNOSTICS 510(k) NO: K083260(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317 521 3225 9115 HAGUE ROAD P.O. BOX 50457 SE DECISION MADE: 16-OCT-09 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 J. MORITA USA, INC. 510(k) NO: K091065(TRADITIONAL)
ATTN: KEITH BARRITT PHONE NO : 202 783 5070 1425 K STREET NW SUITE 1100 SE DECISION MADE: 16-OCT-09 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDED MEASUREMENT CATHETER (GMC) MEDIGUIDE, LTD. 510(k) NO: K091780(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH ST NW COLUMBIA SQUASE DECISION MADE: 16-OCT-09 WASHINGTON DC 20004 1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR WELL LEAD MEDICAL CO. LTD 510(k) NO: K091516(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 16-OCT-09 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYPHER DICOM PRINT SOLUTION VIRTUAL IMAGING, INC. 510(k) NO: K092280(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847 374 8854 333 MILFORD RD. SE DECISION MADE: 16-OCT-09 DEERFIELD IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS BAYLIS MEDICAL CO., INC. 510(k) NO: K092337(SPECIAL)
ATTN: MEGHAL KHAKHAR PHONE NO : 905 602 4875 2645 MATHESON BLVD. E SE DECISION MADE: 16-OCT-09 MISSISSAUGA, ONTARIO CA L4W 5S4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IDENTEVENT, VERSION 1.0G OPTIMA NEUROSCIENCE, INC. 510(k) NO: K092039(TRADITIONAL)
ATTN: PAULA WILKERSON PHONE NO : 352 262 8220 12337 NW 9TH LANE SE DECISION MADE: 16-OCT-09 NEWBERRY FL 32669 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ABX PENTRA TPU CAL, MODEL A11A01898 HORIBA ABX SAS 510(k) NO: K092570(ABBREVIATED)
ATTN: CAROLINE FERRER PHONE NO : 334 671 41843 PARC EUROMEDECINE RUE DU CADUCEE, SE DECISION MADE: 16-OCT-09 MONTPELLIER FR 34184 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE. GEMORE TECHNOLOGY CO., LTD. 510(k) NO: K091833(TRADITIONAL)
ATTN: BODEN LAI PHONE NO : 886 288 091799 11 FL, NO. 29-5, SEC. 2 CHUNG CHENSE DECISION MADE: 16-OCT-09 TAN SHUI, TAIPEI HSIEN TW 251 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDED MEDICAL POSITIONING SYSTEM (GMPS) MEDIGUIDE, LTD. 510(k) NO: K091781(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEENTH ST NW COLUMBIA SQUASE DECISION MADE: 16-OCT-09 WASHINGTON DC 20004 1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 BECKMAN COULTER, INC. 510(k) NO: K091846(TRADITIONAL)
ATTN: MARINE BOYAJIAN PHONE NO : 714 961 6536 200 SOUTH KRAEMER BLVD. W-110 SE DECISION MADE: 16-OCT-09 BREA CA 92822 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBEL/PROCERA IMPLANT BRIDGE NOBEL BIOCARE AB 510(k) NO: K091848(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714 282 4800 22715 SAVI RANCH PARKWAY SE DECISION MADE: 16-OCT-09 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SJM ATTUNE ANNULOPLASTY RING ST. JUDE MEDICAL 510(k) NO: K092876(SPECIAL)
ATTN: THOMAS TADEMACHER PHONE NO : 651 756 6473 177 EAST COUNTY ROAD B SE DECISION MADE: 16-OCT-09 ST. PAUL MN 55117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER VALLEYLAB 510(k) NO: K092879(SPECIAL)
ATTN: PHILIP E AKE PHONE NO : 303 581 6934 5920 LONGBOW DR. SE DECISION MADE: 16-OCT-09 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 EP MEDSYSTEMS 510(k) NO: K092913(SPECIAL)
ATTN: SUSHMA RAO PHONE NO : 856 753 8533 575 RT. 73 NORTH, BLDG. D SE DECISION MADE: 16-OCT-09 WEST BERLIN NJ 08091 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISTRACTABLE WAVE CAGE ADVANCED MEDICAL TECHNOLOGY, INC. 510(k) NO: K083626(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 19-OCT-09 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONMED LINVATEC PRESTO PRELOADED WITH ONE OR TWO #2 HI-FI SUTURES CONMED LINVATEC 510(k) NO: K092898(SPECIAL)
ATTN: LORNA K LINVILLE PHONE NO : 727 399 5396 11311 CONCEPT BOULEVARD SE DECISION MADE: 19-OCT-09 LARGO FL 33773 4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150 COEUR, INC. 510(k) NO: K090487(TRADITIONAL)
ATTN: DEBRA MANNING PHONE NO : 615 547 7927 704 CADET COURT SE DECISION MADE: 19-OCT-09 LEBANON TN 37087 510(k) STATEMENT DEVICE: POWDER FREE NITRILE EXAMINATION GLOVES, BLACK PT. SMART GLOVE INDONESIA 510(k) NO: K092034(TRADITIONAL)
ATTN: SOON TUCK KWAN PHONE NO : 62 617 940100 JL RAYA MEDAN-LUBUK PAKAM KM19 TANSE DECISION MADE: 19-OCT-09 MORAWA,DELI SERDANG,SUMATERA U 510(k) STATEMENT DEVICE: APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR SORIN GROUP ITALIA S.R.L. 510(k) NO: K092895(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781 434 4742 195 WEST STREET SE DECISION MADE: 19-OCT-09 WALTHAM MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOREX INTRA-OPERATIVE LOAD SENSOR ORTHOSENSOR, INC. 510(k) NO: K090474(TRADITIONAL)
ATTN: JON WARD PHONE NO : 813 645 2855 962 ALLEGRO LN. SE DECISION MADE: 19-OCT-09 APOLLO BEACH FL 33572 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LENSTAR, MODEL LS900 HAAG-STREIT AG 510(k) NO: K082891(TRADITIONAL)
ATTN: LENA SATTLER PHONE NO : 440 554 3706 1667 RIDGEWOOD ROAD SE DECISION MADE: 20-OCT-09 WADSWORTH OH 44281 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLONIC SPLINTING OVERTUBE, MODEL 00711145 UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K092221(TRADITIONAL)
ATTN: CRAIG L MOORE PHONE NO : 440 639 4494 5976 HEISELY RD. SE DECISION MADE: 20-OCT-09 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNI 2 OXYGEN SYSTEM SEQUAL TECHNOLOGIES, INC. 510(k) NO: K083163(TRADITIONAL)
ATTN: BRIAN JARRELL PHONE NO : 858 202 3157 11436 SORRENTO VALLEY RD. SE DECISION MADE: 20-OCT-09 SAN DIEGO CA 92121 1393 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POLY-CHEM 90 GLUCOSE POLYMEDCO, INC. 510(k) NO: K090703(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206 262 7363 510 FURNACE DOCK RD. SE DECISION MADE: 20-OCT-09 CORTLANDT MANOR NY 10567 510(k) STATEMENT DEVICE: ESTECH EASYFLOW CANNULA WITH GUIDEWIRE ENDOSCOPIC TECHNOLOGIES, INC. D/B/510(k) NO: K091542(TRADITIONAL)
ATTN: TAMER IBRAHIM PHONE NO : 925 866 7111 2603 CAMINO RAMON SUITE 100 SE DECISION MADE: 20-OCT-09 SAN RAMON CA 94583 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALCON ULTRACHOPPER ALCON RESEARCH, LTD. 510(k) NO: K091777(TRADITIONAL)
ATTN: MARTIN A KAUFMAN PHONE NO : 949 753 6250 15800 ALTON PARKWAY SE DECISION MADE: 20-OCT-09 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMS AIR-FLOW HANDY PERIO EMS ELECTRO MEDICAL SYSTEMS SA 510(k) NO: K092289(TRADITIONAL)
ATTN: CYNTHIA J NOLTE PHONE NO : 919 859 4207 49 PLAIN ST. SE DECISION MADE: 20-OCT-09 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REJUVENATE MODULAR STEM HOWMEDICA OSTEONICS CORP 510(k) NO: K092561(SPECIAL)
ATTN: ESTELA CELI PHONE NO : 201 831 6461 325 CORPORATE DR. SE DECISION MADE: 20-OCT-09 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES NONIN MEDICAL, INC. 510(k) NO: K092101(SPECIAL)
ATTN: LORI ROTH PHONE NO : 763 577 3093 13700 1ST AVE. NORTH SE DECISION MADE: 21-OCT-09 PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LARGE FACE ANEROID SPHYGMOMANOMETER, WALL MODEL, DESK MODEL, MOBILE STAND MODEL, MODEL 41XX, 42XX, 43XX TRIMLINE MEDICAL PRODUCTS CORP. 510(k) NO: K092604(ABBREVIATED)
ATTN: NANCY SKOCYPEC PHONE NO : 908 429 0590 34 COLUMBIA AVE. SE DECISION MADE: 21-OCT-09 BRANCHBURG NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAVEN PROTEST - STEAM BIOLOGICAL INDICATOR RAVEN BIOLOGICAL LABORATORIES, INC510(k) NO: K082756(TRADITIONAL)
ATTN: WENDY ROYALTY-HANN PHONE NO : 402 593 0781 8607 PARK DR. SE DECISION MADE: 21-OCT-09 OMAHA NE 68127 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROCALM MODEL 1 AND 2 NEUROMED DEVICES, INC 510(k) NO: K090866(TRADITIONAL)
ATTN: ROBERT SEIPLE PHONE NO : 940 390 0961 29461 TROON ST SE DECISION MADE: 21-OCT-09 LAGUNA NIGEL CA 92677 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING ACRYMED, INC. 510(k) NO: K091354(TRADITIONAL)
ATTN: CHARLES K GRIFFIN PHONE NO : 503 624 9830 9560 SW NIMBUS AVE SE DECISION MADE: 21-OCT-09 BEAVERTON OR 97008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH BIOCARE CORP. 510(k) NO: K091414(TRADITIONAL)
ATTN: JUDY WEI PHONE NO : 886 326 16678 4F, NO 12, LANE 5, SEC, 2 NANSHAN SE DECISION MADE: 21-OCT-09 TAOYUAN TW 33852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) SHEN WEI (USA), INC. 510(k) NO: K092411(TRADITIONAL)
ATTN: ALBERT LI PHONE NO : 510 429 8692 33278 CENTRAL AVE., SUITE 102 SE DECISION MADE: 21-OCT-09 UNION CITY CA 94587 510(k) STATEMENT DEVICE: REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K092425(TRADITIONAL)
ATTN: AMANDA BABCOCK PHONE NO : 480 763 5376 10232 SOUTH 51ST ST. SE DECISION MADE: 21-OCT-09 PHOENIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K092283(TRADITIONAL)
ATTN: KATHLEEN ANN DRAY-LYONS PHONE NO : 781 826 4551 500 GBC DRIVE M/S 514 PO BOX 6101 SE DECISION MADE: 21-OCT-09 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINYL CO-POLMER FREE EXAMINATION GLOVES, BLUE COLOR BETTERCARE PLASTIC PRODUCTS CO., L510(k) NO: K092294(TRADITIONAL)
ATTN: JIE LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 21-OCT-09 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE EXAMINATION GLOVE BETTERCARE PLASTIC PRODUCTS CO., L510(k) NO: K092296(TRADITIONAL)
ATTN: JIE LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 21-OCT-09 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH PROTEIN LABELING CLAIM OF 50 MICROGRAMS PER DM2 O WEAR SAFE (MALAYSIA) SDN. BHD. 510(k) NO: K092492(TRADITIONAL)
ATTN: S H TAN PHONE NO : 603 329 12657 LOT PT 13726,JALAN HAJI SALLEH OFFSE DECISION MADE: 21-OCT-09 KLANG, SELANGOR, DARUL EHSAN M510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695 ALPHAPROTECH, INC. 510(k) NO: K092824(ABBREVIATED)
ATTN: DAVID KITCHEN PHONE NO : 801 355 5816 236 NORTH 2200 WEST SE DECISION MADE: 21-OCT-09 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST NANOSPHERE, INC 510(k) NO: K092957(SPECIAL)
ATTN: GREGORY SHIPP PHONE NO : 847 400 9115 4088 COMMERCIAL AVENUE SE DECISION MADE: 21-OCT-09 NORTHBROOK IL 60062 510(k) STATEMENT DEVICE: EASYPLUS MINI MASTERDRIVER SELF MONITORING BLOOD GLUCOSE SYSTEM, MODEL EPS09009 EPS BIO TECHNOLOGY CORP. 510(k) NO: K092887(SPECIAL)
ATTN: Y.C. LEI PHONE NO : 886 357 52522 2 F,NO. 49-2, LANE 2, SEC. 2, GUANSE DECISION MADE: 21-OCT-09 HSINCHU CITY TW 30071 510(k) STATEMENT DEVICE: MODIFICATION TO: RAMP INFLUENZA A/B ASSAY RESPONSE BIOMEDICAL CORP. 510(k) NO: K093116(SPECIAL)
ATTN: KEN PILGRIM PHONE NO : 604 456 6010 1781 - 75TH AVENUE W. SE DECISION MADE: 21-OCT-09 VANCOUVER, B.C CA V6P 6P2 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K092882(TRADITIONAL)
ATTN: RONALD H LOLLAR PHONE NO : 740 580 3300 1055 EAST STATE STREET SUITE 100 SE DECISION MADE: 21-OCT-09 ATHENS OH 45701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 CAO GROUP, INC. 510(k) NO: K092616(TRADITIONAL)
ATTN: ROBERT K LARSEN PHONE NO : 801 256 9282 4628 WEST SKYHAWK DRIVE SE DECISION MADE: 21-OCT-09 WEST JORDAN UT 84084 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERAFORM BILAYER SEWON CELLONTECH CO., LTD. 510(k) NO: K090823(TRADITIONAL)
ATTN: EUGENE BANG PHONE NO : 562 404 8466 13340 E. FIRESTONE BLVD. SUITE J SE DECISION MADE: 22-OCT-09 SANTA FE SPRINGS CA 90670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EQUALSHIELD LUER LOCK CONNECTOR PAIR PLASTMED, LTD. 510(k) NO: K091389(SPECIAL)
ATTN: ELISSA BURG PHONE NO : 972 498 73737 BUILDING 7 P.O.B. 26 SE DECISION MADE: 22-OCT-09 TEFEN INDUSTRIAL PARK IS 24959 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIROX ZENCERA INC 510(k) NO: K092630(TRADITIONAL)
ATTN: SANHO HYUN PHONE NO : 822 210 90955 197-22 GURO-3DONG, GURO-GU SE DECISION MADE: 22-OCT-09 SEOUL KS 152766 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEBP ENKO LTD. 510(k) NO: K092783(TRADITIONAL)
ATTN: SINAN KAZAZOGLU PHONE NO : 090 232 3767806 10006 SOKAK, NO.64, A.O.S.B. SE DECISION MADE: 22-OCT-09 CIGLI - IZMIR TU 35620 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK) BETTERCARE PLASTIC PRODUCTS CO., L510(k) NO: K092301(TRADITIONAL)
ATTN: JIE LIU PHONE NO : 909 590 1611 3973 SCHAEFER AVE SE DECISION MADE: 22-OCT-09 CHINO CA 91710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC ECG, MODEL SE-1010 EDAN INSTRUMENTS, INC. 510(k) NO: K092010(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914 376 5200 1 ODELL PLAZA SE DECISION MADE: 22-OCT-09 YONKERS NY 10701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) KENSEY NASH CORP. 510(k) NO: K091499(TRADITIONAL)
ATTN: ALYSSA SCHWARTZ PHONE NO : 484 713 2100 735 PENNSYLVANIA DRIVE SE DECISION MADE: 22-OCT-09 EXTON PA 19341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOCAD IQ CADENT, INC. 510(k) NO: K082207(TRADITIONAL)
ATTN: LAURIE CLARKE PHONE NO : 202 626 2945 1700 PENNSYLVANIA AVE NW SE DECISION MADE: 23-OCT-09 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 SUN-RAIN SYSTEM CORP. 510(k) NO: K090542(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829 NO. 58, FU-CHIUN ST. SE DECISION MADE: 23-OCT-09 HSIN-CHU CITY TW 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CURIOS PROGENTIX ORTHOBIOLOGY B.V. 510(k) NO: K090641(TRADITIONAL)
ATTN: YVONNE P BOVELL PHONE NO : 31 302 297280 PROF. BRONKHORSTLAAN 10 BLDG. 48 SE DECISION MADE: 23-OCT-09 BILTHOVEN NL 3723MB 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARPATH EASYGLIDE LTD. 510(k) NO: K091305(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR. SE DECISION MADE: 23-OCT-09 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMET ANTERIOR CERVICAL PLATE SYSTEM APOLLO SPINE, INC. 510(k) NO: K090751(SPECIAL)
ATTN: ANN-MARIE FRANCIS PHONE NO : 781 828 4400 75 MILL STREET SE DECISION MADE: 23-OCT-09 STOUGHTON MA 02072 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT HOWMEDICA OSTEONICS CORP 510(k) NO: K090897(TRADITIONAL)
ATTN: AVITAL MERL-MARGULIES PHONE NO : 201 831 6365 325 CORPORATE DR. SE DECISION MADE: 23-OCT-09 MAHWAH NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS ARKRAY FACTORY USA, INC. 510(k) NO: K091102(TRADITIONAL)
ATTN: HAMID IDRISSI PHONE NO : 952 646 3171 5182 WEST 76TH ST. SE DECISION MADE: 23-OCT-09 MINNEAPOLIS MN 55439 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERTAPLEX HV (SINGLE PACK AND DUAL PACK) STRYKER CORP. 510(k) NO: K091606(TRADITIONAL)
ATTN: BECKY E DITTY PHONE NO : 269 323 7700 4100 EAST MILHAM AVE. SE DECISION MADE: 23-OCT-09 KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DK50 DS EKOM S.R.O. 510(k) NO: K091871(SPECIAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DRIVE SE DECISION MADE: 23-OCT-09 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALPHAMED SURGICAL SPEAR, MODEL 70-5000 ALPHAMED INC. 510(k) NO: K091240(TRADITIONAL)
ATTN: JAMES GUBACHY PHONE NO : 915 595 2020 3912 MOUNTAIN AVE. SE DECISION MADE: 23-OCT-09 EL PASO TX 79930 510(k) STATEMENT DEVICE: ENTRACARE GASTROSTOMY FEEDING TUBE ENTRACARE, LLC 510(k) NO: K092418(TRADITIONAL)
ATTN: BRANDON CONVERSE PHONE NO : 913 451 2234 11315 STRANGE LINE RD. SE DECISION MADE: 23-OCT-09 LENEXA KS 66215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM INTERLACE MEDICAL, INC. 510(k) NO: K091100(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202 637 5794 555 THIRTEEN STREET, N.W. SE DECISION MADE: 23-OCT-09 WASHINGTON DC 20010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERFACE ACETABULAR CUP LINERS OMNI LIFE SCIENCE, INC. 510(k) NO: K092443(SPECIAL)
ATTN: WILLIAM MCCALLUM PHONE NO : 508 824 2444 175 PARAMOUNT DRIVE SE DECISION MADE: 23-OCT-09 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GAS TRANSFILL RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K091191(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1740 GOLDEN MILE HWY SE DECISION MADE: 23-OCT-09 MONROEVILLE PA 15146 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMD 6605 TENS/NMES ADVANTAGEOUS MEDICAL DEVICES, LLC 510(k) NO: K092990(TRADITIONAL)
ATTN: JOHN HEROD PHONE NO : 757 351 0832 1728 VIRGINIA BEACH BLVD SUITE 115SE DECISION MADE: 23-OCT-09 VIRGINIA BEACH VA 23454 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K092456(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 MDI CONSULTANTS, INC. 55 NORTHERN SE DECISION MADE: 23-OCT-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIPIVIEW OCULAR SURFACE INTERFEROMETER TEARSCIENCE, INC. 510(k) NO: K091935(TRADITIONAL)
ATTN: CHRISTY STEVENS PHONE NO : 919 467 4007 1101 G AVIATION PKWY SE DECISION MADE: 23-OCT-09 MORRISVILLE NC 27560 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JAZZY FRONTIE PRIDE MOBILITY PRODUCTS CORP. 510(k) NO: K092961(SPECIAL)
ATTN: KIMBERLY BLAKE PHONE NO : 570 655 5574 182 SUSQUEHANNA AVE. SE DECISION MADE: 23-OCT-09 EXETER PA 18643 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K092919(SPECIAL)
ATTN: SHANNON POPSON PHONE NO : 916 374 3330 1584 ENTERPRISE BLVD SE DECISION MADE: 23-OCT-09 WEST SACRAMENTO CA 95691 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIS QUATRO SENSOR ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K093183(TRADITIONAL)
ATTN: VIKRAM VERMA PHONE NO : 617 559 7134 1 UPLAND ROAD SE DECISION MADE: 23-OCT-09 NORWOOD MA 02062 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ULC SPINAL PEDICLE SCREW SYSTEM OTIS BIOTECH CO., LTD 510(k) NO: K083077(TRADITIONAL)
ATTN: JISUK YOO PHONE NO : 82 313 190406 514, 2-BA BLOCK, JUNGWANG-DONG SIHSE DECISION MADE: 26-OCT-09 SIHUNG CITY, KYONGGI-DO KS 429-510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KNEEKG EMOVI 510(k) NO: K091000(TRADITIONAL)
ATTN: EMMANUEL MONTINI PHONE NO : 514 397 8500 1100,BOUL. RENE-LEVESQUE OUEST 25 SE DECISION MADE: 26-OCT-09 MONTREAL, QUEBEC CA H3B 5C9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAVI WIRELESS, MODEL PM500 MEDICOMP, INC. 510(k) NO: K091696(SPECIAL)
ATTN: SUSAN GOLDSTEIN-FALK PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 26-OCT-09 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) ALFA WASSERMANN, INC. 510(k) NO: K091413(TRADITIONAL)
ATTN: HYMAN KATZ PHONE NO : 973 852 0158 4 HENDERSON DR. SE DECISION MADE: 26-OCT-09 WEST CALDWELL NJ 07006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSTRUMED VASCULAR CLAMPS INSTRUMED INTERNATIONAL, INC. 510(k) NO: K092544(TRADITIONAL)
ATTN: MICHAEL MASSONG PHONE NO : 847 908 0292 626 COOPER COURT SE DECISION MADE: 26-OCT-09 SCHAUMBURG IL 60173 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K093058(SPECIAL)
ATTN: JENNIFER MCBRIDE PHONE NO : 901 396 3133 1800 PYRAMID PL. SE DECISION MADE: 26-OCT-09 MEMPHIS TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANKLE ARTHRODESIS PLATE SYSTEM TORNIER, INC. 510(k) NO: K090139(TRADITIONAL)
ATTN: BRAHIM HADRI PHONE NO : 978 232 9997 100 CUMMINGS CENTER SUITE 444C SE DECISION MADE: 27-OCT-09 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOW & HIGH SPEED KIT DPM USA CORP. 510(k) NO: K090055(TRADITIONAL)
ATTN: GEORGE ECHEVERRI PHONE NO : 305 640 9894 1460 NW 107 AVE. SUITE G SE DECISION MADE: 27-OCT-09 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K091446(SPECIAL)
ATTN: SHARON TIMBERLAKE, RAC, CCRPHONE NO : 781 993 2414 82 CAMBRIDGE ST. SE DECISION MADE: 27-OCT-09 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRS GLENOID RESURFACING SYSTEM ARTHROSURFACE, INC. 510(k) NO: K091196(TRADITIONAL)
ATTN: DAWN J WILSON PHONE NO : 508 520 3003 28 FORGE PARKWAY SE DECISION MADE: 27-OCT-09 FRANKLIN MA 02038 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR; VERSION 2A: ADHESIVE LABEL STERIS CORPORATION 510(k) NO: K091174(ABBREVIATED)
ATTN: ROBERT F SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY RD. SE DECISION MADE: 27-OCT-09 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVILAS LASER SYSTEM OD -OS GMBH 510(k) NO: K091064(TRADITIONAL)
ATTN: JUDY GORDON PHONE NO : 949 715 0609 733 BOLSANA DRIVE SE DECISION MADE: 27-OCT-09 LAGUNA BEACH CA 92651 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERIT LAUREATE HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K092303(TRADITIONAL)
ATTN: SUSAN CHRISTENSEN PHONE NO : 801 208 4789 1600 WEST MERIT PKWY. SE DECISION MADE: 27-OCT-09 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FLUID ISOLATION DEVICE LENSTEC, INC. 510(k) NO: K091915(TRADITIONAL)
ATTN: JIMMY CHACKO PHONE NO : 727 571 2272 1765 COMMERCE AVE N SE DECISION MADE: 27-OCT-09 ST. PETERSBURG FL 33716 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC. 510(k) NO: K092281(TRADITIONAL)
ATTN: KIYOYUKI ARIKAWA PHONE NO : 212 986 2230 600 LEXINGTON AVENUE 26TH FLOOR SE DECISION MADE: 27-OCT-09 NEW YORK NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION IBALANCE MEDICAL, INC. 510(k) NO: K092381(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST., 29TH FL. SE DECISION MADE: 27-OCT-09 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT BIOMET, INC. 510(k) NO: K092150(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574 267 6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 27-OCT-09 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REVERSE SHOULDER PROSTHESIS DJO SURGICAL 510(k) NO: K092873(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255 9800 METRIC BOULEVARD SE DECISION MADE: 27-OCT-09 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACACIA PISTON SYRINGE ACACIA, INC. 510(k) NO: K092986(TRADITIONAL)
ATTN: FERGIE FERGUSON PHONE NO : 714 257 0470 785 CHALLENGER STREET SE DECISION MADE: 27-OCT-09 BREA CA 92821 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GIVEN ELECTROSURGICAL NEEDLE TRIPPS COURT ENTERPRISES, INC 510(k) NO: K082584(TRADITIONAL)
ATTN: JULIE STEPHENS PHONE NO : 678 513 6093 111 LAUREL RIDGE DRIVE SE DECISION MADE: 28-OCT-09 ALPHARETTA GA 30004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA AFFINITY BIOLOGICALS INC. 510(k) NO: K091284(TRADITIONAL)
ATTN: DENISE FOULON PHONE NO : 905 304 9896 1395 SANDHILL DRIVE SE DECISION MADE: 28-OCT-09 ANCASTER, ONTARIO CA L9G 4V5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS ZIMMER GMBH 510(k) NO: K091566(TRADITIONAL)
ATTN: DANIEL J WILLIMAN PHONE NO : 574 371 8065 P.O. BOX 708 SE DECISION MADE: 28-OCT-09 WARSAW IN 46581 0708 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS XPULSE 805 IR LAMP SYSTEM, NEXUS XPULSE 980 IR LAMP SYSTEM, MODEL 805, 980 USA LASER BIOTECH INC. 510(k) NO: K091726(TRADITIONAL)
ATTN: JOYCE HEINRICH PHONE NO : 713 734 4433 12101 CULLEN BLVD., # A SE DECISION MADE: 28-OCT-09 HOUSTON TX 77047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL R & D SYSTEMS, INC. 510(k) NO: K091433(SPECIAL)
ATTN: NANCY RING PHONE NO : 612 379 2956 614 MCKINLEY PL., N.E. SE DECISION MADE: 28-OCT-09 MINNEAPOLIS MN 55413 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 HONSUN (NANTONG) CO., LTD 510(k) NO: K092245(TRADITIONAL)
ATTN: DAVID ZHANG PHONE NO : 008 605 1385986718 ADD: NO8 TONGXING ROAD SE DECISION MADE: 28-OCT-09 JIANGSU CH 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHECKPOINT NDI MEDICAL LLC 510(k) NO: K092292(TRADITIONAL)
ATTN: JULIE GRILL PHONE NO : 919 968 4690 22901 MILLCREEK BOULEVARD SUITE 11SE DECISION MADE: 28-OCT-09 CLEVELAND OH 44122 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NORM SPINAL SYSTEM NORM TIBBI URUNLER ITHALAT IHRACAT510(k) NO: K092011(TRADITIONAL)
ATTN: NURAY DOGAN PHONE NO : 903 122 840080 1CADDE NO:5/1 BALGAT SE DECISION MADE: 28-OCT-09 ANKARA TU 06520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K091984(TRADITIONAL)
ATTN: CLARE SANTULLI PHONE NO : 914 524 2701 5210 PACIFIC CONCOURSE DR. SE DECISION MADE: 28-OCT-09 LOS ANGELES CA 90045 6900 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACELL MATRISTEM WOUND SHEET ACELL, INC 510(k) NO: K092926(SPECIAL)
ATTN: RODNEY W BOSLEY PHONE NO : 410 715 1700 8671 ROBERT FULTON DRIVE SUITE B SE DECISION MADE: 28-OCT-09 COLUMBIA MD 21046 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AZUR PERIPHERAL HYDROCOIL ENDOVASCULAR EMBOLIZATION SYSTEM-DETACHABLE 35, MODELS 45-450405, 45-450410, 45-450610 MICROVENTION, INC. 510(k) NO: K093002(SPECIAL)
ATTN: NAOMI GONG PHONE NO : 714 247 8055 1311 VALENCIA AVE SE DECISION MADE: 28-OCT-09 TUSTIN CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTISPOT RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM SQI DIAGNOSTICS SYSTEMS 510(k) NO: K083080(TRADITIONAL)
ATTN: KATE SMITH PHONE NO : 416 674 9500 36 METEOR DR. SE DECISION MADE: 29-OCT-09 TORONTO, ONTARIO CA M9W 1A4 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 MAQUET CARDIOPULMONARY AG 510(k) NO: K090689(TRADITIONAL)
ATTN: INGRID RICHTER PHONE NO : 497 478 921337 HECHINGER STRASSE 38 SE DECISION MADE: 29-OCT-09 HIRRLINGEN GM 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 ETHICON ENDO-SURGERY, INC. 510(k) NO: K091290(TRADITIONAL)
ATTN: TOM BOSTICCO PHONE NO : 513 337 8935 4545 CREEK RD. SE DECISION MADE: 29-OCT-09 CINCINNATI OH 45242 2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT TELEFLEX MEDICAL, INC. 510(k) NO: K091761(ABBREVIATED)
ATTN: WILLIAM HEARD PHONE NO : 919 433 8083 2917 WECK DR. SE DECISION MADE: 29-OCT-09 RESEARCH TRIANGLE PARK NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXELO2, MODEL 4010 QUANTEL DERMA GMBH 510(k) NO: K090639(TRADITIONAL)
ATTN: MICHAEL JOHNSON PHONE NO : 406 586 0131 601 HAGGERTY LN. SE DECISION MADE: 29-OCT-09 BOZEMAN MT 59715 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REEF HP 0.035" OTW PTA BALLOON DILATATION CATHETER INVATEC S.P.A. 510(k) NO: K092361(TRADITIONAL)
ATTN: JOHN CLAY PHONE NO : 610 625 1429 3101 EMRICK BLVD SE DECISION MADE: 29-OCT-09 BETHLEHEM PA 18020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNOVANCE D-DIMER, MODEL OPBP09 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K091916(TRADITIONAL)
ATTN: KATHLEEN ANN DRAY-LYONS PHONE NO : 781 826 4551 500 GBC DRIVE PO BOX 6101 SE DECISION MADE: 29-OCT-09 NEWARK DE 19714 6101 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOLISA ANTI-HAV IGM EIA BIO-RAD LABORATORIES, INC. 510(k) NO: K092353(TRADITIONAL)
ATTN: LINDA STASWICK PHONE NO : 425 498 1696 6565 185TH AVE., N.E. SE DECISION MADE: 29-OCT-09 REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONOLISA ANTI-HAV EIA BIO-RAD LABORATORIES, INC. 510(k) NO: K092355(TRADITIONAL)
ATTN: LINDA STASWICK PHONE NO : 425 498 1696 6565 185TH AVE., N.E. SE DECISION MADE: 29-OCT-09 REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PTFE PEELABLE INTRODUCER GREATBATCH MEDICAL 510(k) NO: K093023(SPECIAL)
ATTN: KRISTI FOX PHONE NO : 763 951 8181 2300 BERKSHIRE LANE NORTH SE DECISION MADE: 29-OCT-09 MINNEAPOLIS MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OMNIGUIDE BEAMPATH FELS 25A CO2 LASER SYSTEM OMNIGUIDE, INC. 510(k) NO: K093251(TRADITIONAL)
ATTN: DOUGLAS W WOODRUFF PHONE NO : 617 551 8404 ONE KENDALL SQUARE, BLDG 100 3RD FSE DECISION MADE: 29-OCT-09 CAMBRIDGE MA 02139 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS ANDOVER HEALTHCARE INC. 510(k) NO: K083133(TRADITIONAL)
ATTN: VALERIE GUNN PHONE NO : 978 465 0065 9 FANARAS DR. SE DECISION MADE: 30-OCT-09 SALISBURY MA 01952 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES SPINECRAFT 510(k) NO: K090887(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 30-OCT-09 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPAP AUTOSV ADVANCED RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K090539(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724 387 4120 1001 MURRY RIDGE LN. SE DECISION MADE: 30-OCT-09 MURRYSVILLE PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET SYNERGETICS, INC. 510(k) NO: K091441(TRADITIONAL)
ATTN: GARY OLIVEROS PHONE NO : 636 794 5107 3845 CORPORATE CENTRE DR. SE DECISION MADE: 30-OCT-09 O'FALLON MO 63368 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUILD-IT LIGHT CURE PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K091512(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVE SE DECISION MADE: 30-OCT-09 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECO2 LASER SYSTEM LUTRONIC CORPORATION 510(k) NO: K091115(SPECIAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978 207 1245 5 TIMBER LANE SE DECISION MADE: 30-OCT-09 NORTH READING MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI TECH IMPLANT, HT PHYSIO IMPLANT BY DENTAL SRL 510(k) NO: K091913(TRADITIONAL)
ATTN: DANIELE POLI PHONE NO : 390 573 994355 VIA VECCHIA PROV. LE LUCCHESE 49/FSE DECISION MADE: 30-OCT-09 SERRAVALLE POLI; PISTOIA IT 510510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 DANIELS CORPORATION PTY, INC. 510(k) NO: K091736(TRADITIONAL)
ATTN: ANDREA ARREDONDO PHONE NO : 540 818 0783 2133-126 UPTON DRIVE SUITE 436 SE DECISION MADE: 30-OCT-09 VIRGINIA BEACH VA 23454 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MITS DICOM GATEWAY AND IMAGE MANAGER MITSMED MEDICAL INSTRUMENT TECHNOL510(k) NO: K092581(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58 FU CHIUN STREET SE DECISION MADE: 30-OCT-09 HSIN CHU CITY TW 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS RUBELLA IGGA CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K092585(TRADITIONAL)
ATTN: KELLY FRENCH PHONE NO : 317 521 3208 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 30-OCT-09 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K092309(TRADITIONAL)
ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 30-OCT-09 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620 ZIMMER DENTAL INC. 510(k) NO: K092403(TRADITIONAL)
ATTN: LARISSA D ANDREA MCMULLIN PHONE NO : 760 929 4300 1900 ASTON AVE. SE DECISION MADE: 30-OCT-09 CARLSBAD CA 92008 7308 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX DENTIMAX 510(k) NO: K092547(TRADITIONAL)
ATTN: KORINA A AKHONDZADEH PHONE NO : 760 798 9642 6965 EL CAMINO REAL SUITE 105-482 SE DECISION MADE: 30-OCT-09 CARLSBAD CA 92009 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE BAXTER HEALTHCARE CORPORATION 510(k) NO: K092318(TRADITIONAL)
ATTN: VALERIE FOLLOWELL PHONE NO : 847 270 4375 1620 WAUKEGAN RD. MPGR-AL SE DECISION MADE: 30-OCT-09 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: F.A.S.T. SYSTEM SED AND CXD GENESIS MEDICAL INTERVENTIONAL, IN510(k) NO: K092623(SPECIAL)
ATTN: ANNE WORDEN PHONE NO : 925 426 8927 3637 BERNAL AVENUE SE DECISION MADE: 30-OCT-09 PLEASANTON CA 94566 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIODENTINE SEPTODONT 510(k) NO: K092251(TRADITIONAL)
ATTN: WAYNE MATELSKI PHONE NO : 202 857 6340 1050 CONNECTICUT AVE., NW SE DECISION MADE: 30-OCT-09 WASHINGTON DC 20036 510(k) STATEMENT DEVICE: SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 THE SMARTPILL CORPORATION 510(k) NO: K092342(TRADITIONAL)
ATTN: KATHLEEN SELOVER PHONE NO : 716 882 0701 847 MAIN ST. SE DECISION MADE: 30-OCT-09 BUFFALO NY 14203 1109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALINDROME P HEMODIALYSIS CATHETER COVIDIEN LP, FORMERLY REGISTERED A510(k) NO: K092205(TRADITIONAL)
ATTN: DANIEL CAMPION PHONE NO : 504 452 4132 15 HAMPSHIRE ST. SE DECISION MADE: 30-OCT-09 MANSFIELD MA 02048 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPINAL FIXATION SYSTEM LANX, INC. 510(k) NO: K092536(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267 675 4611 1835 MARKET ST. SUITE 2820 SE DECISION MADE: 30-OCT-09 PHILADELPHIA PA 19103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIRECT DIGITIZER, REGIUS MODEL 210 KONICA MINOLTA MEDICAL & GRAPHIC, 510(k) NO: K092717(SPECIAL)
ATTN: RUSSEL MUNVES PHONE NO : 212 490 4100 140 EAST 45TH ST., 25TH FLOOR TWO SE DECISION MADE: 30-OCT-09 NEW YORK NY 10017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRATED REGISTRATION GE MEDICAL SYSTEMS SCS 510(k) NO: K093234(TRADITIONAL)
ATTN: SOPHIE LE LOARER PHONE NO : 331 307 04331 283 RUE DE LA MINIERE BP 34 SE DECISION MADE: 30-OCT-09 BUC CEDEX FR 78533 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES CARDINAL HEALTH, INC. 510(k) NO: K093300(TRADITIONAL)
ATTN: TATYANA BOGDAN PHONE NO : 847 578 2325 1430 WAUKEGAN ROAD SE DECISION MADE: 30-OCT-09 MCGAW PARK IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II DENTSPLY INTL., INC. 510(k) NO: K093221(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717 845 7511 SUSQUEHANNA COMMERCE CENTER 221 W SE DECISION MADE: 30-OCT-09 YORK PA 17404 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 254 TOTAL WITH SUMMARIES 234 TOTAL WITH STATEMENTS 20
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