Medical Devices
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March 2010 510(k) Clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD March 2010 DEVICE: HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS THE BINDING SITE GROUP LTD 510(k) NO: K082823(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310 449 1399 12100 WILSHIRE BLVD SUITE 500 SE DECISION MADE: 01-MAR-10 LOS ANGELES CA 90025 7121 510(k) STATEMENT DEVICE: NMI FC NAVILYST MEDICAL, INC. 510(k) NO: K091634(ABBREVIATED)
ATTN: SHILPA PREM PHONE NO : 508 658 7954 26 FOREST STREET SE DECISION MADE: 01-MAR-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GEL FILLED GUM SOOTHER LUV N' CARE, LTD. 510(k) NO: K092494(TRADITIONAL)
ATTN: JOSEPH H HAKIM PHONE NO : 318 338 3172 3030 AURORA AVE., 2ND FLOOR SE DECISION MADE: 01-MAR-10 MONROE LA 71201 510(k) STATEMENT DEVICE: ECHOPLAQUE INDEC SYSTEMS, INC. 510(k) NO: K092842(TRADITIONAL)
ATTN: CAROL HUBLER PHONE NO : 408 986 1600 2210 MARTIN AVE. SE DECISION MADE: 01-MAR-10 SANTA CLARA CA 95050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS DIAGNOSTIC GROUP LLC 510(k) NO: K092244(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952 278 4457 7625 GOLDEN TRIANGLE DR. SE DECISION MADE: 01-MAR-10 EDEN PRAIRIE MN 55344 510(k) STATEMENT DEVICE: DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 CHANGZHOU WASTON MEDICAL APPLIANCE510(k) NO: K100386(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 84973 SUITE 5D, NO 19, LANE 999 ZHONGSHASE DECISION MADE: 01-MAR-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASHE WOUND CLEANSING SYSTEM PURICORE INC. 510(k) NO: K093155(TRADITIONAL)
ATTN: DENNIS MAHONEY PHONE NO : 484 321 2724 508 LAPP RD. SE DECISION MADE: 01-MAR-10 MALVERN PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS SMITHS MEDICAL ASD, INC. 510(k) NO: K093414(TRADITIONAL)
ATTN: RACHELLE PARSONS PHONE NO : 651 628 7018 1265 GREY FOX ROAD SE DECISION MADE: 01-MAR-10 ST. PAUL MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL ULTRASOUND SCANNER SHENZHEN WELL.D MEDICAL ELECTRONIC510(k) NO: K100079(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 STE 5D NO.19, LANE 999, ZHONGSHAN SE DECISION MADE: 01-MAR-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# OSTEOGENICS BIOMEDICAL, INC. 510(k) NO: K093719(TRADITIONAL)
ATTN: DUSTYN WEBB PHONE NO : 806 796 1923 4620 71ST ST., BLDG. 78-79 SE DECISION MADE: 01-MAR-10 LUBBOCK TX 79424 510(k) STATEMENT DEVICE: C-MOR VISUALIZATION DEVICE AXIS SURGICAL TECHNOLOGIES, INC 510(k) NO: K093717(TRADITIONAL)
ATTN: JAMES FARNWORTH PHONE NO : 650 968 3800 325 E. MIDDLEFIELD RD SE DECISION MADE: 02-MAR-10 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM BIOTEST MEDICAL CORP. 510(k) NO: K093764(SPECIAL)
ATTN: MAGGIE CHU PHONE NO : 866 425 326668 NO.3-2, CHIEN-KUO ROAD, TEPZ TANTZSE DECISION MADE: 02-MAR-10 TAICHUNG TW 427 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHROMID VRE AGAR, MODEL: REF 43 851 BIOMERIEUX, INC. 510(k) NO: K091025(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314 731 8695 595 ANGLUM RD. SE DECISION MADE: 02-MAR-10 HAZELWOOD MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A-GRIX RESORBABLE BONE VOID FILLER AG DIGITAL TECHNOLOGY CORP. 510(k) NO: K091688(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928 853 6340 2904 N. BOLDT DRIVE SE DECISION MADE: 02-MAR-10 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K092902(SPECIAL)
ATTN: DEBRA LIANG PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 02-MAR-10 TAIPEI COUNTY TW 24888 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDACTA BIPOLAR HEAD MEDACTA INTERNATIONAL, SA 510(k) NO: K091967(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858 705 0350 13721 VIA TRES VISTA SE DECISION MADE: 02-MAR-10 SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANAPNOGUARD ENDOTRACHEAL TUBE HOSPITECH RESPIRATION LTD. 510(k) NO: K093126(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST SE DECISION MADE: 02-MAR-10 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GS III SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K091208(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 888 678 0001 85 BEN FAIRLESS DR. SE DECISION MADE: 03-MAR-10 FAIRLESS HILLS PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL SYNTHES (USA) 510(k) NO: K090658(TRADITIONAL)
ATTN: JILL R YELTON PHONE NO : 610 719 6538 1301 GOSHEN PKWY. SE DECISION MADE: 03-MAR-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; ENCORE MEDICAL, L.P. 510(k) NO: K092331(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512 834 6255 9800 METRIC BLVD. SE DECISION MADE: 03-MAR-10 AUSTIN TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COLOR LCD MONITOR, MODEL RADIFORCE RS210 EIZO NANAO CORPORATION 510(k) NO: K092613(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468 153 SHIMOKASHIWANO, HAKUSAN SE DECISION MADE: 03-MAR-10 ISHIKAWA JA 924-8566 510(k) STATEMENT DEVICE: GRINDCARE MEDOTECH A/S 510(k) NO: K092675(TRADITIONAL)
ATTN: CALLEY HERZOG PHONE NO : 720 883 3633 13417 QUIVAS ST SE DECISION MADE: 03-MAR-10 WESTMINSTER CO 80234 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VINTAGE MP SHOFU DENTAL CORP. 510(k) NO: K093559(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760 736 3277 1225 STONE DR. SE DECISION MADE: 03-MAR-10 SAN MARCOS CA 92078 510(k) STATEMENT DEVICE: ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K093812(TRADITIONAL)
ATTN: SHELLY PEARCE PHONE NO : 650 694 5988 1230 SHOREBIRD WAY SE DECISION MADE: 03-MAR-10 MOUNTAIN VIEW CA 94043 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE ANTHOGYR 510(k) NO: K093894(SPECIAL)
ATTN: BRAYETTE SABINE PHONE NO : 33 4 50580237 2237 AVENUE ANDRE LASQUIN SE DECISION MADE: 03-MAR-10 SALLANCHES FR 74700 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MD300C1 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K093757(SPECIAL)
ATTN: YAJING LI PHONE NO : 86 10 88790480 NORTH BUILDING 3F, NO.9 SHUANGYUANSE DECISION MADE: 03-MAR-10 SHIJINGSHAN DISTRICT, BEIJING C510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MGB DISPOSABLE RETRIEVAL BAG LAPBAG MGB ENDOSKOPISCHE GERATE GMBH (BER510(k) NO: K093194(TRADITIONAL)
ATTN: PATRICK GAENSICKE PHONE NO : 49 30 63927000 SCHWARZSCHILDSTRASSE 6 SE DECISION MADE: 03-MAR-10 BERLIN GM D-12489 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIT KIT - FREEZE AND THAW IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K093273(TRADITIONAL)
ATTN: JAYME YAMAGUCHI-OWENS PHONE NO : 800 437 5706 2511 DAIMLER ST SE DECISION MADE: 03-MAR-10 SANTA ANA CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZEISS INFRARED 800 WITH FLOW 800 OPTION CARL ZEISS SURGICAL GMBH 510(k) NO: K100468(TRADITIONAL)
ATTN: JUDITH BRIMACOMBE PHONE NO : 925 557 4616 5160 HACIENDA DRIVE SE DECISION MADE: 03-MAR-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TEMP IT SPIDENT CO., LTD. 510(k) NO: K100413(TRADITIONAL) ATTN: I.S. WHANG PHONE NO : 823 281 94570 312, 151B-6L NAMDONGGONGDAN SE DECISION MADE: 03-MAR-10 INCHEON KS 405-821 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BLOM-SINGER INDWELLING TEP OCCLUDER HELIX MEDICAL, LLC 510(k) NO: K093258(SPECIAL)
ATTN: CYNTHIA ANDERSON PHONE NO : 805 576 5497 1110 MARK AVE. SE DECISION MADE: 03-MAR-10 CARPINTERIA CA 93013 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER ACCLARENT, INC. 510(k) NO: K093594(SPECIAL)
ATTN: COURTNEY KALOF PHONE NO : 650 687 4473 1525-B O'BRIEN DR. SE DECISION MADE: 03-MAR-10 MENLO PARK CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP HYDROLIFT VBR SYSTEM AESCULAP IMPLANT SYSTEM, INC. 510(k) NO: K083186(TRADITIONAL)
ATTN: MATHEW M HULL PHONE NO : 610 984 9072 3773 CORPORATE PARKWAY SE DECISION MADE: 04-MAR-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VRLXP, MODEL XP DEEP BREEZE LTD. 510(k) NO: K091732(TRADITIONAL)
ATTN: JEFF BAETZ PHONE NO : 202 822 1850 2001 PENNSYLVANIA AVENUE NW SUITE SE DECISION MADE: 04-MAR-10 WASHINGTON DC 20006 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE THERMAL THERAPEUTIC SYSTEMS, INC 510(k) NO: K092366(TRADITIONAL)
ATTN: JAMES J ROGERS PHONE NO : 724 713 2298 PO BOX 961 SE DECISION MADE: 04-MAR-10 MOON TOWNSHIP PA 15108 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART CAPNOLINE GUARDIAN ORIDION MEDICAL 1987 LTD. 510(k) NO: K093388(TRADITIONAL)
ATTN: RACHEL WEISSBROD PHONE NO : 972 258 99115 7 HAMARPE ST. P.O.B. 45025 HAR HOTSE DECISION MADE: 04-MAR-10 JERUSALEM IS 91450 510(k) STATEMENT DEVICE: MICRO-TOUCH NITRILE ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K093523(ABBREVIATED)
ATTN: CYNTHIA A INGRAM PHONE NO : 334 615 2563 1635 INDUSTRIAL RD. SE DECISION MADE: 04-MAR-10 DOTHAN AL 36303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 AVITA CORPORATION 510(k) NO: K100016(SPECIAL)
ATTN: JENNIFER REICH PHONE NO : 928 863 8140 2904 N. BOLDT DR. SE DECISION MADE: 04-MAR-10 FLAGSTAFF AZ 86001 510(k) STATEMENT DEVICE: TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET ZIMMER TRABECULAR METAL TECHNOLOGY510(k) NO: K093127(TRADITIONAL)
ATTN: KATHLEEN RUTHERFORD PHONE NO : 973 576 0139 10 POMEROY RD. SE DECISION MADE: 04-MAR-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOSTART BURETTE ANALYTICA PTY LTD 510(k) NO: K092905(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715 549 6035 PO BOX 560 SE DECISION MADE: 04-MAR-10 STILLWATER MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS WHIP-MIX CORP. 510(k) NO: K092857(TRADITIONAL)
ATTN: STUART STEINBOCK PHONE NO : 502 634 1451 361 FARMINGTON AVE. P.O. BOX 17183SE DECISION MADE: 04-MAR-10 LOUISVILLE KY 40209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPI DENTAL IMPLANT, ELEMENT THOMMEN MEDICAL, AG 510(k) NO: K093615(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858 792 1235 11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 04-MAR-10 SAN DIEGO CA 92130 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) WOMANCARE GLOBAL 510(k) NO: K093508(TRADITIONAL)
ATTN: SUSANNE PARKS PHONE NO : 919 442 2621 300 MARKET ST. SUITE 134 SE DECISION MADE: 04-MAR-10 CHAPEL HILL NC 27516 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS HCG STAT CALCHECK 5 ROCHE DIAGNOSTICS CORP. 510(k) NO: K093700(TRADITIONAL)
ATTN: KELLY C O'MAINE ADAMS PHONE NO : 317 521 3577 9115 HAGUE RD. P.O. BOX 50410 SE DECISION MADE: 04-MAR-10 INDIANAPOLIS IN 46250 0416 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K093897(TRADITIONAL)
ATTN: CHRISTINA FLORES PHONE NO : 508 261 3705 150 MINUTEMAN RD. SE DECISION MADE: 04-MAR-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUALASE CAPSULE WASH TIP ALCON MANUFACTURING, LTD. 510(k) NO: K093210(TRADITIONAL)
ATTN: MARTIN A KAUFMAN PHONE NO : 949 753 6250 15800 ALTON PKWY. SE DECISION MADE: 04-MAR-10 IRVINE CA 92618 3818 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO.PLAZA SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K093612(TRADITIONAL)
ATTN: PHONE NO : HENKESTRASSE 127 SE DECISION MADE: 04-MAR-10 ERLANGEN GM 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SINGLE-PATIENT USE DISPOSABLE SENSOR NONIN MEDICAL, INC. 510(k) NO: K093306(SPECIAL)
ATTN: LORI ROTH PHONE NO : 763 577 3093 13700 1ST AVE. NORTH SE DECISION MADE: 04-MAR-10 PLYMOUTH MN 55441 5443 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EVOLUTION MP TOTAL KNEE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K093552(TRADITIONAL)
ATTN: RYAN ROSS PHONE NO : 901 867 4401 5677 AIRLINE RD. SE DECISION MADE: 04-MAR-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HAMILTON-C2 HAMILTON MEDICAL AG 510(k) NO: K092148(TRADITIONAL)
ATTN: JOERG SCHNEIDER PHONE NO : 41 81 6606010 VIA CRUSCH 8 SE DECISION MADE: 04-MAR-10 BONADUZ SZ CH-7402 510(k) STATEMENT DEVICE: RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR JIANGSU CUREGUARD GLOVE CO., LTD. 510(k) NO: K093576(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 ROOM 1606 BLDG. 1 JIANX. YUAN NO. SE DECISION MADE: 04-MAR-10 HAIDIAN DISTRICT, BEIJING CH 10510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED ULTRASONIC COAGULATING SHEARS ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K093702(TRADITIONAL)
ATTN: MOIRA BARTON VARTY PHONE NO : 480 763 5350 10232 SOUTH 51ST ST. SE DECISION MADE: 04-MAR-10 PHOENIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES 510(k) NO: K100297(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD. SE DECISION MADE: 04-MAR-10 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEREOS WORKSTATION BIOSPACE MED 510(k) NO: K090050(TRADITIONAL)
ATTN: JOHN J SMITH PHONE NO : 202 637 3638 555 THIRTEENTH ST. NW SE DECISION MADE: 05-MAR-10 WASHINGTON DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THERATEST EL-ANTI-CCP/2 THERATEST LABORATORIES, INC. 510(k) NO: K090753(TRADITIONAL)
ATTN: MARIUS TEODORESCU PHONE NO : 630 627 6069 1111 N. MAIN ST. SE DECISION MADE: 05-MAR-10 LOMBARD IL 60148 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REFINE SUPPORT SYSTEM, MODEL 100.0100 ALURE MEDICAL INC. 510(k) NO: K092538(TRADITIONAL)
ATTN: JOSEPH TAMAYO PHONE NO : 707 526 4400 3637 WESTWIND BLVD., SUITE B SE DECISION MADE: 05-MAR-10 SANTA ROSA CA 95403 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 ABBOTT LABORATORIES 510(k) NO: K092740(TRADITIONAL)
ATTN: DARLA ABANO PHONE NO : 847 937 3461 100 ABBOTT PARK ROAD DEPT. 9V6 AP6SE DECISION MADE: 05-MAR-10 ABBOTT PARK IL 60064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMOOTHCOOL JEISYS MEDICAL, INC. 510(k) NO: K092326(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S. COTTONWOOD CT. SE DECISION MADE: 05-MAR-10 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: P-ART, MODEL 001 P-CURE LTD 510(k) NO: K092424(TRADITIONAL)
ATTN: MICHAEL MARASH PHONE NO : 972 527 504849 4A HAGAVISH ST SE DECISION MADE: 05-MAR-10 NETANYA, HASHARON IS 42101 510(k) STATEMENT DEVICE: DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR SHANTOU INSTITUTE OF ULTRASONIC IN510(k) NO: K092907(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925 556 1302 7263 CRONIN CIRCLE SE DECISION MADE: 05-MAR-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAR-LITE -LM, MODEL SL8809 PS ADVANCED ENGINEERING 510(k) NO: K092460(TRADITIONAL)
ATTN: WEN YANG PHONE NO : 626 642 8885 200 SOUTH GARFIELD AVE SUITE 318 SE DECISION MADE: 05-MAR-10 ALHAMBRA CA 91801 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHESAPEAKE SPINAL SYSTEM K2M, INC. 510(k) NO: K092211(TRADITIONAL)
ATTN: RICHARD WOODS PHONE NO : 703 777 3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 05-MAR-10 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMPI CONTINUUM EMPI 510(k) NO: K093324(TRADITIONAL)
ATTN: JO P CHIU PHONE NO : 423 870 2281 4717 ADAMS ROAD SE DECISION MADE: 05-MAR-10 HIXSON TN 37343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIZZY EXPRESS MYCONE DENTAL SUPPLY CO., INC. 510(k) NO: K093380(TRADITIONAL)
ATTN: NICK PALMER PHONE NO : 856 663 4700 616 HOLLYWOOD AVE. SE DECISION MADE: 05-MAR-10 CHERRY HILL NJ 08002 510(k) STATEMENT DEVICE: COAGUCHEK XS PLUS PST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K092940(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317 521 4569 9115 HAGUE RD. SE DECISION MADE: 05-MAR-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM MEDICAL NUMERICS, INC. 510(k) NO: K093336(TRADITIONAL)
ATTN: DOUGLAS M TUCKER PHONE NO : 240 686 3460 20410 OBSERVATION DRIVE SUITE 210 SE DECISION MADE: 05-MAR-10 GERMANTOWN MD 20876 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GLUMA DESENSITIZER POWER GEL HERAEUS KULZER, LLC 510(k) NO: K093575(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574 299 5444 300 HERAEUS WAY SE DECISION MADE: 05-MAR-10 SOUTH BEND IN 46614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K093943(TRADITIONAL)
ATTN: JULIE ACKER PHONE NO : 508 261 3618 150 MINUTEMAN RD. SE DECISION MADE: 05-MAR-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 OMNI LIFE SCIENCE, INC. 510(k) NO: K094017(SPECIAL)
ATTN: ROBERT ZOLETTI PHONE NO : 774 226 1845 175 PARAMOUNT DRIVE SE DECISION MADE: 05-MAR-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) TANGSHAN ZHONGPU PLASTIC PRODUCTS 510(k) NO: K100058(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441 ROOM 1606 BLDG 1, JIANXIANG YUAN NSE DECISION MADE: 05-MAR-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARFIL MAJETY POSTERIOR KURARAY MEDICAL INC. 510(k) NO: K100328(SPECIAL)
ATTN: KIYOYUKI ARIKAWA PHONE NO : 212 986 2230 600 LEXINGTON AVENUE 26TH FLOOR SE DECISION MADE: 05-MAR-10 NEW YORK NY 10022 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUITY BREAK-AWAY GUIDE CATHETER CARDIAC PACEMAKERS, INC. 510(k) NO: K093969(SPECIAL)
ATTN: KATHLEEN VITTUM PHONE NO : 651 582 4820 4100 HAMLINE AVE., NORTH SE DECISION MADE: 05-MAR-10 ST. PAUL MN 55112 5798 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUATTRO UNOMD CUATTRO, LLC 510(k) NO: K093480(TRADITIONAL)
ATTN: MARK SKEELS PHONE NO : 973 294 4363 40 BRAM BAY ROAD SE DECISION MADE: 05-MAR-10 HOPTACONG NJ 07843 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM BIOMET TRAUMA (AKA EBI, LP) 510(k) NO: K093761(TRADITIONAL)
ATTN: MARGARET CROWE PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 05-MAR-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIRCUFLOW 3001 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. 510(k) NO: K100446(TRADITIONAL)
ATTN: RUTH WU PHONE NO : 800 571 3135 1100 1ST AVENUE SUITE 100 SE DECISION MADE: 05-MAR-10 KING OF PRUSSIA PA 19406 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: EXL ANEM CAL, MODEL RC640 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K093645(TRADITIONAL)
ATTN: ANNA M KATHLEEN ENNIS PHONE NO : 302 631 9352 500 GBC DRIVE M/S 514 PO BOX 6101 SE DECISION MADE: 05-MAR-10 NEWARK DE 19714 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTISCAN MODEL OPTISCAN CEIS OPTISCAN PTY LTD. 510(k) NO: K093624(TRADITIONAL)
ATTN: PETER PAVLICEK PHONE NO : 613 953 83333 15-17 NORMANBY RD. SE DECISION MADE: 05-MAR-10 NOTTING HILL VIC AS 3168 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 1.5T AND 3.0T GENERAL PURPOSE FLEX COILS INVIVO CORPORATION 510(k) NO: K093842(TRADITIONAL)
ATTN: ELIZABETH WHEELER PHONE NO : 352 336 0010 3545 SW 47TH AVE SE DECISION MADE: 05-MAR-10 GAINESVILLE FL 32608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SITE-RITE VISION ULTRASOUND SYSTEM BARD ACCESS SYSTEMS, INC. 510(k) NO: K100402(TRADITIONAL)
ATTN: KIMBERLY GEISLER PHONE NO : 801 522 0700 605 NORTH 5600 WEST SE DECISION MADE: 05-MAR-10 SALT LAKE CITY UT 84116 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NEONATAL BIOTINIDASE KIT, MODEL 3018 PERKINELMER, INC. 510(k) NO: K090123(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317 418 1735 8275 CARLOWAY ROAD SE DECISION MADE: 05-MAR-10 INDIANAPOLIS IN 46236 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STRYKER ARTHROSCOPE STRYKER ENDOSCOPY 510(k) NO: K093677(TRADITIONAL)
ATTN: SHIBIR DESAI PHONE NO : 408 754 2540 5900 OPTICAL CT. SE DECISION MADE: 05-MAR-10 SAN JOSE CA 95138 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROCYN SKIN AND WOUND HYDROGEL OCULUS INNOVATIVE SCIENCES, INC. 510(k) NO: K093585(TRADITIONAL)
ATTN: ANTOINETTE DOUGLAS PHONE NO : 707 559 2445 1129 N. MCDOWELL BLVD. SE DECISION MADE: 08-MAR-10 PETALUMA CA 94954 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K093788(TRADITIONAL)
ATTN: CHARLES MORGANSON PHONE NO : 978 379 8309 6 TECH DRIVE SE DECISION MADE: 08-MAR-10 ANDOVER MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DX SERIES FINGER SENSOR DIXTAL MEDICAL INC. 510(k) NO: K100020(SPECIAL)
ATTN: ROBERT SCHIFFMAN PHONE NO : 203 269 1112 101 N. Plains Industrial Rd. BuildSE DECISION MADE: 08-MAR-10 Wallingford CT 06492 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POC-AS10 AUTO SAMPLER OTSUKA PHARMACEUTICAL CO., LTD. 510(k) NO: K092817(TRADITIONAL)
ATTN: CYNTHIA A SINCLAIR PHONE NO : 508 643 0434 49 PLAIN ST. SE DECISION MADE: 09-MAR-10 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES MENICON CO. LTD. 510(k) NO: K082855(TRADITIONAL)
ATTN: BEVERLEY D VENUTI PHONE NO : 978 658 6888 187 BALLARDVALE STREET SUITE 180 SE DECISION MADE: 09-MAR-10 WILMINGTON MA 01887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSEO AIR PRESSURE MASSAGER THE AMERICAN EXPORT GROUP & INTERN510(k) NO: K092435(TRADITIONAL)
ATTN: ROBERT WAGNER PHONE NO : 865 982 5552 1131 ANTHEM VIEW LANE SE DECISION MADE: 09-MAR-10 KNOXVILLE TN 37922 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MATRIX MIS RODS SYNTHES (USA) 510(k) NO: K093668(TRADITIONAL)
ATTN: HEATHER GUERIN PHONE NO : 610 719 5432 1302 WRIGHTS LANE EAST SE DECISION MADE: 09-MAR-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: E1 ANTIOXIDANT INFUSED TECHNOLOGY BIOMET MANUFACTURING CORP. 510(k) NO: K100048(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574 267 6639 PO BOX 587 SE DECISION MADE: 09-MAR-10 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PSL CLASSIC SLIT LAMP KEELER INSTRUMENTS, INC. 510(k) NO: K100500(TRADITIONAL)
ATTN: EUGENE VANARSDALE PHONE NO : 610 353 4350 456 PKWY. SE DECISION MADE: 09-MAR-10 BROOMALL PA 19008 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM BIOMET SPINE 510(k) NO: K093629(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 09-MAR-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEARPATH UGI EASYGLIDE LTD. 510(k) NO: K093779(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239 498 2155 24301 WOODSAGE DR. SE DECISION MADE: 09-MAR-10 BONITA SPRINGS FL 34134 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOCLEAR SYSTEM VIRTUAL PORTS LTD 510(k) NO: K100346(SPECIAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA STREET SE DECISION MADE: 10-MAR-10 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. 510(k) NO: K091520(TRADITIONAL)
ATTN: KEVIN LAWSON PHONE NO : 716 691 0091 60 PINEVIEW DR. SE DECISION MADE: 10-MAR-10 BUFFALO NY 14228 2120 510(k) STATEMENT DEVICE: VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH 3M ESPE DENTAL PRODUCTS 510(k) NO: K092141(TRADITIONAL)
ATTN: TAMARA L STANCZAK PHONE NO : 651 737 2807 3M CENTER, BLDG 275-2W-08 SE DECISION MADE: 10-MAR-10 ST PAUL MN 55144 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS LLC 510(k) NO: K092545(SPECIAL)
ATTN: LARRY LEPLEY PHONE NO : 608 226 3415 2902 DAIRY DR. SE DECISION MADE: 10-MAR-10 MADISON WI 53718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INBODY, MODELS: 270, R20, R20B BIOSPACE CORPORATION LIMITED 510(k) NO: K092786(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 239 234 1735 8726 FERRARA CT. SE DECISION MADE: 10-MAR-10 NAPLES FL 34114 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER INTERSURGICAL, INC. 510(k) NO: K092409(TRADITIONAL)
ATTN: MICHAEL ZALEWSKI PHONE NO : 315 451 2900 417 ELECTRONICS PKWY. SE DECISION MADE: 10-MAR-10 LIVERPOOL NY 13088 510(k) STATEMENT DEVICE: CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM CONMED CORPORATION 510(k) NO: K092414(ABBREVIATED)
ATTN: SANDY COVELESKI PHONE NO : 315 624 3435 525 FRENCH RD. SE DECISION MADE: 10-MAR-10 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO NEOMED, INC. 510(k) NO: K092908(TRADITIONAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678 428 6978 717 LAKEGLEN DR. SE DECISION MADE: 10-MAR-10 SUWANEE GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 BOVIE MEDICAL CORPORATION 510(k) NO: K092383(TRADITIONAL)
ATTN: RICHARD KOZLOFF PHONE NO : 727 803 8513 5115 Ulmerton Road SE DECISION MADE: 10-MAR-10 Clearwater FL 33760 0000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLARUJUST AUDIGENCE, INC. 510(k) NO: K092089(TRADITIONAL)
ATTN: CRAIG PAGAN PHONE NO : 321 728 0125 1050 W. NASA BLVD. SUITE 154 SE DECISION MADE: 10-MAR-10 MELBOURNE FL 32901 510(k) STATEMENT DEVICE: INTEGRATED LABORATORY AUTOMATION SOLUTION INTEGRATED LABORATORY AUTOMATION S510(k) NO: K091975(TRADITIONAL)
ATTN: MARIA F GRIFFIN PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 10-MAR-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED NEXUS MEDICAL, LLC 510(k) NO: K092930(SPECIAL)
ATTN: HEATHER TURNER PHONE NO : 913 451 2234 11315 STRANG LINE ROAD SE DECISION MADE: 10-MAR-10 LENEXA KS 66215 510(k) STATEMENT DEVICE: XVI R4.5 ELEKTA LTD. 510(k) NO: K100115(TRADITIONAL)
ATTN: ANDREW HEDGES PHONE NO : 441 293 654201 FLEMING WAY SE DECISION MADE: 10-MAR-10 CRAWLEY UK RH10 9RR 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 CARDINAL HEALTH 207, INC. 510(k) NO: K093124(SPECIAL)
ATTN: MONTHER ABUSHABAN PHONE NO : 714 919 3660 22745 SAVI RANCH PARKWAY SE DECISION MADE: 10-MAR-10 YORBA LINDA CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXCITE F AND EXCITE DSC IVOCLAR VIVADENT, INC. 510(k) NO: K093744(TRADITIONAL)
ATTN: DONNA MARIE HARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 10-MAR-10 AMHERST NY 14228 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATTIOLI PULSE TWO/THREE PLUS FAMILY MATTIOLI ENGINEERING CORP. 510(k) NO: K100053(TRADITIONAL)
ATTN: GIANFRANCO BERNABEI PHONE NO : 703 243 5991 8300 GREENSBORO DR. SUITE 800 SE DECISION MADE: 10-MAR-10 MCLEAN VA 22102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D KCI USA, INC. (KINETIC CONCEPTS, I510(k) NO: K093526(TRADITIONAL)
ATTN: RANDALL WHEELAND PHONE NO : 210 515 4126 6203 FARINON DRIVE SE DECISION MADE: 10-MAR-10 SAN ANTONIO TX 78249 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS AMSINO INTERNATIONAL, INC. 510(k) NO: K093773(SPECIAL)
ATTN: JESUS FARINAS PHONE NO : 909 626 5888 855 TOWNE CENTER DR. SE DECISION MADE: 10-MAR-10 POMONA CA 91767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PULPDENT FLUORIDE VARNISH PULPDENT CORPORATION 510(k) NO: K093620(TRADITIONAL)
ATTN: KENNETH J BERK PHONE NO : 617 926 6666 80 OAKLAND ST. P.O. BOX 780 SE DECISION MADE: 10-MAR-10 WATERTOWN MA 02471 0780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK TELEFLEX MEDICAL 510(k) NO: K100506(SPECIAL)
ATTN: VALERIE FOLLOWELL PHONE NO : 262 925 8274 5307 95TH AVENUE SE DECISION MADE: 10-MAR-10 KENOSHA WI 53144 510(k) STATEMENT DEVICE: OLYMPUS CHF TYPE Y0003 OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K093507(TRADITIONAL)
ATTN: STACY ABBATIELLO KLUESNER PHONE NO : 484 896 5405 3500 CORPORATE PARKWAY PO BOX 610 SE DECISION MADE: 10-MAR-10 CENTER VALLEY PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TC PLATING SYSTEM ORTHO-PRO LLC 510(k) NO: K094037(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 10-MAR-10 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FIXIT HEADREST CLAMP SYSTEM MEDICON, E.G. 510(k) NO: K083803(TRADITIONAL)
ATTN: JOACHIM SCHMID PHONE NO : 497 462 2009-0 GAENSAECKER 15 SE DECISION MADE: 10-MAR-10 TUTTLINGEN GM D-78532 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) DIAMOND DIAGNOSTICS, INC. 510(k) NO: K093384(TRADITIONAL)
ATTN: KATHY CRUZ PHONE NO : 508 429 0450 333 FISKE ST. SE DECISION MADE: 10-MAR-10 HOLLISTON MA 01746 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELIO CAD IVOCLAR VIVADENT, INC. 510(k) NO: K093708(TRADITIONAL)
ATTN: DONNA MHARTNETT PHONE NO : 716 691 0010 175 PINEVIEW DR. SE DECISION MADE: 10-MAR-10 AMHERST NY 14228 510(k) STATEMENT DEVICE: CARESTREAM IMAGE SUITE CARESTREAM HEATLH, INC. 510(k) NO: K100094(TRADITIONAL)
ATTN: JOHN PARDO PHONE NO : 585 627 6543 150 VERONA STREET SE DECISION MADE: 11-MAR-10 ROCHESTER NY 14608 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L ORGAN RECOVERY SYSTEMS, INC. 510(k) NO: K091656(TRADITIONAL)
ATTN: PJ PARDO PHONE NO : 847 824 2600 2570 EAST DEVON AVE SE DECISION MADE: 11-MAR-10 DES PLAINES IL 60018 4912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS K2M, INC. 510(k) NO: K092474(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 703 777 3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 11-MAR-10 LEESBURG VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS INSTRUMENTATION LABORATORY CO. 510(k) NO: K092181(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781 861 4467 113 HARTWELL AVE. SE DECISION MADE: 11-MAR-10 LEXINGTON MA 02421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION COVIDIEN, FORMERLY NELLCOR PURITAN510(k) NO: K092847(TRADITIONAL)
ATTN: JEAN SIMON PHONE NO : 303 305 2435 6135 GUNBARREL AVE. SE DECISION MADE: 11-MAR-10 BOULDER CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELL LEAD ENDOBRONCHIAL TUBES WELL LEAD INSTRUMENTS 510(k) NO: K092886(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813 645 2855 962 ALLEGRO LANE SE DECISION MADE: 11-MAR-10 APOLLO BEACH FL 33570 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IGUIDE CAPPA CAS INNOVATIONS GMBH & CO. KG 510(k) NO: K093787(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 31 20 6125626 AMSTEL 320-I SE DECISION MADE: 11-MAR-10 AMSTERDAM, NH NL 1017AP 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART 510(k) NO: K093936(SPECIAL)
ATTN: FRANCK PENNESI PHONE NO : 41 22 7994025 COINTRIN 20 ROUTE DE PRE-BOIS CP18SE DECISION MADE: 11-MAR-10 GENEVA SZ 1215 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 PANPAC MEDICAL CORPORATION 510(k) NO: K092980(TRADITIONAL)
ATTN: YEN-MING PAN PHONE NO : 886 286 472242 NO. 202, 6F-1.2, SEC.3 TATONG ROADSE DECISION MADE: 11-MAR-10 SHI-CHIH CITY, TAIPEI HSIEN TW 510(k) STATEMENT DEVICE: SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR ST. SHINE OPTICAL CO., LTD. 510(k) NO: K092852(TRADITIONAL)
ATTN: BRIAN LAI PHONE NO : 886 226 479356 4,5 F/L NO. 276-2 SEC. 1 TATUNG RDSE DECISION MADE: 11-MAR-10 TAIPEI HSIEN TW 221 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIAGNOSOFT HARP MODEL 1.1.0 DIAGNOSOFT, INC. 510(k) NO: K100352(SPECIAL)
ATTN: JEFFREY ROBERTS PHONE NO : 508 643 0434 49 PLAIN STREET SE DECISION MADE: 11-MAR-10 NORTH ATTLEBORO MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX STRYKER CORP. 510(k) NO: K093864(SPECIAL)
ATTN: KIMBERLY S LANE PHONE NO : 201 760 8215 2 PEARL COURT SE DECISION MADE: 11-MAR-10 ALLENDALE NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: C. ALBICANS/C. GLABRATA PNA FISH ADVANDX, INC. 510(k) NO: K092784(TRADITIONAL)
ATTN: HENRIK STENDER PHONE NO : 781 376 0009 10A ROESSLER ROAD SE DECISION MADE: 12-MAR-10 WOBURN MA 01801 510(k) STATEMENT DEVICE: COAXIAL APPLICATOR SYSTEM BIOMET, INC. 510(k) NO: K091722(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574 372 1502 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 12-MAR-10 WARSAW IN 46581 0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS MEDACTA INTERNATIONAL, SA 510(k) NO: K092265(TRADITIONAL)
ATTN: NATALIE KENNEL PHONE NO : 858 705 0350 13721 VIA TRES VISTA SE DECISION MADE: 12-MAR-10 SAN DIEGO CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS RUBELLA IGM IMMUNOASSAY ROCHE DIAGNOSTICS 510(k) NO: K092322(TRADITIONAL)
ATTN: THERESA A BUSH PHONE NO : 317 521 3723 9115 HAGUE ROAD SE DECISION MADE: 12-MAR-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIQUICHEK OPIATE CONTROL BIO-RAD LABORATORIES 510(k) NO: K093577(TRADITIONAL)
ATTN: ELIZABETH PLATT PHONE NO : 949 598 1285 9500 JERONIMO RD. SE DECISION MADE: 12-MAR-10 IRVINE CA 92618 2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER SONOSCAPE COMPANY LIMITED 510(k) NO: K092922(TRADITIONAL)
ATTN: BOB LEIKER PHONE NO : 925 556 1302 7263 CRONIN CIRCLE SE DECISION MADE: 12-MAR-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 ACTHERM, INC. 510(k) NO: K093795(SPECIAL)
ATTN: RICHARD HSIEH PHONE NO : 886 366 69596 6F, NO.18 JHANYE 2ND RD., HSINCHU SE DECISION MADE: 12-MAR-10 HSINCHU TW 30078 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIDGET WORLD REPORTS BAYER HEALTHCARE LLC 510(k) NO: K093930(SPECIAL)
ATTN: SUSAN BROCCHI PHONE NO : 914 333 6736 777 OLD SAW MILL RIVER ROAD SE DECISION MADE: 12-MAR-10 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 MILLIPORE CORPORATION 510(k) NO: K093815(TRADITIONAL)
ATTN: CATHERINE KARAMAN PHONE NO : 951 676 8080 28820 SINGLE OAK DR. SE DECISION MADE: 12-MAR-10 TEMECULA CA 92590 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES CARL ZEISS MEDITEC INC 510(k) NO: K093213(TRADITIONAL)
ATTN: JUDITH A BRIMACOMBE PHONE NO : 925 557 4616 5160 HACIENDA DR. SE DECISION MADE: 12-MAR-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VCARE DX CONMED CORPORATION 510(k) NO: K093556(TRADITIONAL)
ATTN: SARAH RIZK PHONE NO : 315 624 3219 525 FRENCH RD. SE DECISION MADE: 12-MAR-10 UTICA NY 13502 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR GE HEALTHCARE FINLAND OY 510(k) NO: K093881(SPECIAL)
ATTN: TOMMI JOKINIEMI PHONE NO : 358 103 9411 KUORTANEENKATU 2 SE DECISION MADE: 12-MAR-10 HELSINKI FI FIN-00510 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAYSTATION VERSION 1.0 RAYSEARCH LABORATORIES AB 510(k) NO: K100552(TRADITIONAL)
ATTN: ANDERS MURMAN PHONE NO : 46 8 54506130 SVEAVAGEN 25, PLAN 9 SE DECISION MADE: 12-MAR-10 STOCKHOLM SW SE-111 34 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES SOLARIS MEDICAL TECHNOLOGY, INC. 510(k) NO: K092950(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949 706 7456 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 12-MAR-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EZLASE 3 LASER SYSTEM BIOLASE TECHNOLOGY, INC. 510(k) NO: K093852(TRADITIONAL)
ATTN: IOANA RIZOIU PHONE NO : 949 226 8144 4 CROMWELL SE DECISION MADE: 12-MAR-10 IRVINE CA 92618 1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZR DENTAL BLOCK AMS CO., LTD 510(k) NO: K093571(TRADITIONAL)
ATTN: CLAUDE YANG PHONE NO : 082 256 63360 #708 LE-MEILLEUR TOWN 837-19 GANGNSE DECISION MADE: 12-MAR-10 SEOUL KS 135-937 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K091555(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 15-MAR-10 TAIPEI COUNTY TW 24888 510(k) STATEMENT DEVICE: MESH GPS - LARGE, SMALL, SM, SM SMALL SURGICAL STRUCTURES LTD. 510(k) NO: K092726(TRADITIONAL)
ATTN: SHOSH FRIEDMAN PHONE NO : 704 430 8695 1914 J.N. PEASE PLACE SE DECISION MADE: 15-MAR-10 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MBCP+ BIOMATLANTE 510(k) NO: K093122(TRADITIONAL)
ATTN: JEANNE CHAMOUSSET-ROMAN PHONE NO : 332 280 20009 5, RUE EDOUARD BELIN ZA LES QUATRESE DECISION MADE: 15-MAR-10 VIGNEUX DE BRETAGNE FR 44360 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER GREATBATCH MEDICAL 510(k) NO: K093232(TRADITIONAL)
ATTN: SHANNON SPRINGER PHONE NO : 763 951 8181 2300 BERKSHIRE LANE NORTH SE DECISION MADE: 15-MAR-10 PLYMOUTH MN 55441 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VESISCAN LIFE-TECH, INC. 510(k) NO: K093485(TRADITIONAL)
ATTN: JEFF KASOFF PHONE NO : 281 491 6600 13235 NORTH PROMENADE BLVD. SE DECISION MADE: 16-MAR-10 STAFFORD TX 77477 510(k) STATEMENT DEVICE: SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) ALBERT DAVYDOV DDS PC PROFESSIONAL510(k) NO: K092427(TRADITIONAL)
ATTN: ALBERT DAVYDOV PHONE NO : 718 261 4812 109-33 71ST ROAD, 11B SE DECISION MADE: 16-MAR-10 FOREST HILLS NY 11375 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER SPINECRAFT, INC. 510(k) NO: K092825(SPECIAL)
ATTN: AMI AKALLAL-ASAAD PHONE NO : 708 531 9700 2215 ENTREPRISE DR. SE DECISION MADE: 16-MAR-10 WESTCHESTER IL 60154 5804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOPDECH ENDOBRONCHIAL BLOCKER TUBER DAIKEN MEDICAL CO, LTD. 510(k) NO: K093888(TRADITIONAL)
ATTN: FUMIAKI KANAI PHONE NO : 813 381 88577 4-1-17 HONGO, BUNKYO-KU SE DECISION MADE: 16-MAR-10 TOKYO JA 113-0033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OASIS MRI SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K093044(TRADITIONAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330 425 1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 16-MAR-10 TWINSBURG OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 INFIMED, INC. 510(k) NO: K093066(TRADITIONAL)
ATTN: JIGAR SHAH PHONE NO : 516 482 9001 55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 16-MAR-10 GREAT NECK NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEUROSCOUT STEERABLE GUIDEWIRE CODMAN & SHURTLEFF, INC. 510(k) NO: K100351(SPECIAL)
ATTN: JOAN BARTLE PHONE NO : 508 828 2840 325 PARAMOUNT DR. SE DECISION MADE: 16-MAR-10 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPIX MANTA CERVICAL INTERBODY DEVICE MEDICREA 510(k) NO: K100484(SPECIAL) ATTN: J.D. WEBB PHONE NO : 512 388 0199 1001 OAKWOOD BLVD SE DECISION MADE: 16-MAR-10 ROUND ROCK TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYNECARE TVT EXACT CONTINENCE SYSTEM ETHICON, INC. 510(k) NO: K100485(SPECIAL)
ATTN: SUSAN LIN PHONE NO : 908 218 2256 P.O. BOX 151 ROUTE 22 WEST SE DECISION MADE: 16-MAR-10 SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCUBA BILIARY STENT SYSTEM INVATEC S.P.A. 510(k) NO: K092352(TRADITIONAL)
ATTN: STEVE CAMP PHONE NO : 610 625 1402 3101 EMRICK BLVD SE DECISION MADE: 16-MAR-10 BETHLEHEM PA 18020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W QUICKLASE LIMITED 510(k) NO: K100474(TRADITIONAL)
ATTN: CALVIN OSTLER PHONE NO : 801 831 5331 PO BOX 1264, 1094 WEST GREASEWOOD SE DECISION MADE: 16-MAR-10 RIVERTON UT 84065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LITEPAC, MODEL 682 CLEAR STREAM TECHNOLOGIES, LTD. 510(k) NO: K100490(SPECIAL)
ATTN: FIONA NI MHULLAIN PHONE NO : 353 539 237111 MOYNE UPPER, ENNISCORTHY SE DECISION MADE: 16-MAR-10 COUNTY WEXFORD EI 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES HARVARD MEDICAL DEVICES LTD. 510(k) NO: K092558(TRADITIONAL)
ATTN: MARTIN MA PHONE NO : 852 273 20971 39 CHATHAM ROAD SOUTH SE DECISION MADE: 17-MAR-10 TSIMSHATSUI, KOWLOON HK 510(k) STATEMENT DEVICE: OMNITECH LARGE, TRIMED COMPRESSION SCREW TRIMED, INC. 510(k) NO: K093676(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 661 312 7150 25864 TOURNAMENT RD. SUITE A SE DECISION MADE: 17-MAR-10 VALENCIA CA 91355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE HYBRID VASCULAR GRAFT W.L. GORE & ASSOCIATES 510(k) NO: K093934(TRADITIONAL)
ATTN: MICHAEL IVEY PHONE NO : 928 864 3790 3250 W. KILTIE LANE SE DECISION MADE: 17-MAR-10 FLAGSTAFF AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODEL VISULAS 532S LASER WITH THE VITE OPTION CARL ZEISS MEDITEC AG 510(k) NO: K100035(SPECIAL)
ATTN: JUDITH A BRIMACOMBE PHONE NO : 925 557 4616 5160 HACIENDA DRIVE SE DECISION MADE: 17-MAR-10 DUBLIN CA 94568 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K100532(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508 828 3359 325 PARAMOUNT DR. SE DECISION MADE: 17-MAR-10 RAYNHAM MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER NIPRO MEDICAL CORPORATION 510(k) NO: K100520(SPECIAL)
ATTN: JESSICA OSWALD PHONE NO : 305 599 7174 3150 N.W. 107TH AVE. SE DECISION MADE: 17-MAR-10 MIAMI FL 33172 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARMONY VLED SURGICAL LIGHTNING SYSTEM STERIS CORPORATION 510(k) NO: K100395(SPECIAL)
ATTN: ROBERT SULLIVAN PHONE NO : 440 392 7695 5960 HEISLEY RD. SE DECISION MADE: 17-MAR-10 MENTOR OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSACLOSE, MODEL VC-200-01 ANULEX TECHNOLOGIES, INC 510(k) NO: K100572(SPECIAL)
ATTN: RACHEL KENNEDY PHONE NO : 952 224 4000 5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 17-MAR-10 MINNETONKA MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS C.R. BARD, INC. 510(k) NO: K093965(TRADITIONAL)
ATTN: CANDACE WADE PHONE NO : 480 303 2662 1625 WEST 3RD ST. P.O. BOX 1740 SE DECISION MADE: 17-MAR-10 TEMPE AZ 85281 1740 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX TIBIAL GRAFTBOLT ARTHREX, INC. 510(k) NO: K093912(TRADITIONAL)
ATTN: DAVID D'ALESSANDRO PHONE NO : 239 643 5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 18-MAR-10 NAPLES FL 34108 1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINA-QUANT CERULOPLASMIN ROCHE DIAGNOSTICS 510(k) NO: K091741(TRADITIONAL)
ATTN: KATHIE J GOODWIN PHONE NO : 317 521 3831 9115 HAGUE ROAD PO BOX 50416 SE DECISION MADE: 18-MAR-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL RETINAL CAMERA CX-1 CANON COMPONENTS, INC. 510(k) NO: K092565(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516 328 5602 ONE CANON PLAZA SE DECISION MADE: 18-MAR-10 LAKE SUCCESS NY 11042 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 BOVIE MEDICAL 510(k) NO: K092149(TRADITIONAL)
ATTN: RICHARD KOZLOFF PHONE NO : 727 803 8513 5115 ULMERTON ROAD SE DECISION MADE: 18-MAR-10 CLEARWATER FL 33760 4004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFTVIEW, MODEL 2.01 RIVERAIN MEDICAL GROUP 510(k) NO: K092363(TRADITIONAL) ATTN: JENNIFER VETTER PHONE NO : 937 425 6811 3020 SOUTH TECH BLVD. SE DECISION MADE: 18-MAR-10 MIAMISBURG OH 45342 4860 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW ASPYRA, INC. 510(k) NO: K091631(TRADITIONAL)
ATTN: MARTIN D SARGENT PHONE NO : 904 854 2107 8649 BAYPINE RD. SE DECISION MADE: 18-MAR-10 JACKSONVILLE FL 32256 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 NEUROTRONICS, INC. 510(k) NO: K092699(TRADITIONAL)
ATTN: JAMES SCHUBERT PHONE NO : 352 372 9955 912 NE 2ND ST. SE DECISION MADE: 18-MAR-10 GAINESVILLE FL 32601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-OSS COLLAGEN ED. GEISTLICH SOEHNE AG FUER CHEMI510(k) NO: K092428(TRADITIONAL)
ATTN: PETER REICHERTZ PHONE NO : 202 772 5333 1300 I STREET, N.W. 11TH FLOOR EASSE DECISION MADE: 18-MAR-10 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DANA REUSABLE TEST PACK FOR STEAM STERILIZATION DANA PRODUCTS, INC. 510(k) NO: K092944(TRADITIONAL)
ATTN: HARRY BALA PHONE NO : 847 455 2881 7 COREY DR. SE DECISION MADE: 18-MAR-10 SOUTH BARINGTON IL 60010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS STRYKER INSTRUMENTS, INSTRUMENTS D510(k) NO: K093419(TRADITIONAL)
ATTN: BECKY E DITTY PHONE NO : 269 323 7700 4100 EAST MILHAM AVE. SE DECISION MADE: 18-MAR-10 KALAMAZOO MI 49001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, FUJIREBIO DIAGNOSTICS, INC 510(k) NO: K093957(TRADITIONAL)
ATTN: STACEY DOLAN PHONE NO : 610 240 3843 201 GREAT VALLEY PARKWAY SE DECISION MADE: 18-MAR-10 MALVERN PA 19355 1307 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COAGUCHEK XS PRO SYSTEM ROCHE DIAGNOSTICS 510(k) NO: K093460(TRADITIONAL)
ATTN: JENNIFER TRIBBETT PHONE NO : 317 521 4569 9115 HAGUE ROAD SE DECISION MADE: 18-MAR-10 INDIANAPOLIS IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LED LIGHT SOURCE SUNOPTIC TECHNOLOGIES, LLC 510(k) NO: K093792(TRADITIONAL)
ATTN: JANICE G LEE PHONE NO : 904 737 7611 6018 BOWDENDALE AVE. SE DECISION MADE: 18-MAR-10 JACKSONVILLE FL 32216 6042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CP-FIBER (ORTHOFIBER) CP MEDICAL 510(k) NO: K094028(ABBREVIATED)
ATTN: BARBARA K HORTON PHONE NO : 503 232 1555 803 NE 25TH AVE. SE DECISION MADE: 18-MAR-10 PORTLAND OR 97232 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H) RIO FLEXON TECHNOLOGY CO., LTD. 510(k) NO: K100226(SPECIAL)
ATTN: CHI-HUNG LIAO PHONE NO : 886 282 218199 15F,868-2, JHONG JHENG RD., SE DECISION MADE: 18-MAR-10 JHONGHE CITY TAIPEI COUNTY TW 2510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STORM-BASE 2.0 KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K093603(TRADITIONAL)
ATTN: LEIGH SPOTTEN PHONE NO : 424 218 8738 2151 E. GRAND AVE. SE DECISION MADE: 18-MAR-10 EL SEGUNDO CA 90245 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEC IBF CAGE INNVOTEC SURGICAL, INC. 510(k) NO: K093669(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202 552 5800 1331 H STREET NW 12TH FLOOR SE DECISION MADE: 18-MAR-10 WASHINGTON DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: OASYS SYSTEM STRYKER SPINE 510(k) NO: K093670(SPECIAL)
ATTN: PAULINE SHAND PHONE NO : 201 760 8105 2 PEARL COURT SE DECISION MADE: 18-MAR-10 ALLENDALE NJ 07401 1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NBM-200MP PULSE OXIMETRY DEVICE ORSENSE LTD 510(k) NO: K091564(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 976 976 70002 20 HATA'AS ST SE DECISION MADE: 19-MAR-10 KFAR SABA IS 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS TROPONIN T CALCHECK 5 ROCHE DIAGNOSTICS CORP. 510(k) NO: K092848(TRADITIONAL)
ATTN: SARAH BAUMANN PHONE NO : 317 521 3952 9115 HAGUE RD. P.O. BOX 50410 SE DECISION MADE: 19-MAR-10 INDIANAPOLIS IN 46250 0416 510(k) STATEMENT DEVICE: MEDPOR CONTAIN IMPLANT POREX SURGICAL, INC. 510(k) NO: K091120(TRADITIONAL)
ATTN: JERRI L MANN PHONE NO : 770 515 7735 15 DART RD. SE DECISION MADE: 19-MAR-10 NEWNAN GA 30265 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 KIMBERLY-CLARK CORP. 510(k) NO: K093115(TRADITIONAL)
ATTN: MARCIA JOHNSON PHONE NO : 770 587 8566 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 19-MAR-10 ROSWELL GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPROCESSED TROCARS, MODEL B5LT AND CB5LT ASCENT HEALTHCARE SOLUTIONS 510(k) NO: K100080(TRADITIONAL)
ATTN: MOIRA BARTON-VARTY PHONE NO : 480 763 5350 10232 SOUTH 51ST ST. SE DECISION MADE: 19-MAR-10 PHOENIX AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ESTHETICA KERR CORPORATION 510(k) NO: K100083(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714 516 7602 1717 WEST COLLINS AVENUE SE DECISION MADE: 19-MAR-10 ORANGE CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPUS SPEEDSCREW SYSTEM ARTHROCARE CORP. 510(k) NO: K100457(SPECIAL)
ATTN: LAURA N KASPEROWICZ PHONE NO : 949 585 2406 15285 ALTON PARKWAY, #200 SE DECISION MADE: 19-MAR-10 IRVINE CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 SIEMENS HEATLHCARE DIAGNOSTICS INC510(k) NO: K100293(ABBREVIATED)
ATTN: ERNEST JOSEPH PHONE NO : 914 524 2431 511 BENEDICT AVENUE SE DECISION MADE: 19-MAR-10 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SLIT LAMP BO 900, BQ 900, BP900 HAAG-STREIT AG 510(k) NO: K100202(TRADITIONAL)
ATTN: OSCAR BANZ PHONE NO : 413 197 80148 GARTENSTADTSTRASSE 10 SE DECISION MADE: 19-MAR-10 KOENIZ SZ CH-3098 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SMPLE PLATE AND SCREWS BIOMET TRAUMA (AKA EBI, LP) 510(k) NO: K093983(TRADITIONAL)
ATTN: MARGARET CROWE PHONE NO : 973 299 9300 100 INTERPACE PARKWAY SE DECISION MADE: 19-MAR-10 PARSIPPANY NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K093732(ABBREVIATED)
ATTN: KIRA GORDON PHONE NO : 914 524 2996 511 BENEDICT AVENUE SE DECISION MADE: 22-MAR-10 TARRYTOWN NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GORE DRYSEAL SHEATH W.L. GORE & ASSOCIATES,INC 510(k) NO: K093791(TRADITIONAL)
ATTN: ALICIA HEMPHILL PHONE NO : 928 864 4328 3450 WEST KILTIE LANE SE DECISION MADE: 22-MAR-10 FLAGSTAFF AZ 86002 0500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 HOVEROUND CORP. 510(k) NO: K093946(TRADITIONAL)
ATTN: TONY DIGIOVANNI PHONE NO : 941 739 6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 22-MAR-10 SARASOTA FL 34243 510(k) STATEMENT DEVICE: BELRAY II TAKARA BELMONT CORP. 510(k) NO: K093240(TRADITIONAL)
ATTN: KUNIHIKO SOUE PHONE NO : 732 469 5000 101 BELMONT DRIVE SE DECISION MADE: 22-MAR-10 SOMERSET NJ 08873 1204 510(k) STATEMENT DEVICE: 18" STANDARD WHEELCHAIR, MODEL MS005-4, 18" RECLINING WHEELCHAIR , MODEL MS008-1, 14" PEDIATRIC WHEELCHAIR MODERN REHABILITATION SOLUTIONS CO510(k) NO: K094047(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720 962 5412 5401 S COTTONWOOD CT SE DECISION MADE: 22-MAR-10 GREENWOOD VILLAGE CO 80121 510(k) STATEMENT DEVICE: HEARTWAY POWER CHAIR, P23 HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K100327(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 352 08829 ROC CHINESE- EUROPEAN IND. NO.58, SE DECISION MADE: 22-MAR-10 HSIN CHU CITY,,, TW HSQ TW 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT HOVEROUND CORP. 510(k) NO: K100350(TRADITIONAL)
ATTN: TONY GIOVANNI PHONE NO : 941 739 6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 22-MAR-10 SARASOTA FL 34243 510(k) STATEMENT DEVICE: KNEEALIGN SYSTEM WITH REFERENCE SENSOR ORTHALIGN, INC 510(k) NO: K093998(SPECIAL)
ATTN: AMY WALTERS PHONE NO : 949 923 9400 338 VISTA MADERA SE DECISION MADE: 22-MAR-10 NEWPORT BEACH CA 92660 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSTEMS INTEGRATION MODEL: ENDOALPHA OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K100345(SPECIAL)
ATTN: STACY KLUESNER PHONE NO : 484 896 5405 REGULATORY AFFAIRS & QUALITY 3500 SE DECISION MADE: 22-MAR-10 CENTER VALLEY PA 18034 0610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN CHANGRONG GLOVE CO., LTD.510(k) NO: K100339(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 JIANXIANG YUAN NO. 209 BEI SI HUANSE DECISION MADE: 22-MAR-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VPAP III ST-A RESMED LTD. 510(k) NO: K093731(TRADITIONAL)
ATTN: DAVID D'CURZ PHONE NO : 858 836 5984 9001 SPECTRUM CENTER BLVD. SE DECISION MADE: 22-MAR-10 SAN DIEGO CA 92123 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY ANGIOSCORE, INC. 510(k) NO: K100303(TRADITIONAL)
ATTN: KIMBERLEY KLINE PHONE NO : 510 933 7989 5055 BRANDIN COURT SE DECISION MADE: 22-MAR-10 FREMONT CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AUTOLOG AUTOTRANSFUSION SYSTEM MEDTRONIC INC. 510(k) NO: K093535(TRADITIONAL)
ATTN: CARALEE WALTON PHONE NO : 763 514 9851 7611 NORTHLAND DRIVE SE DECISION MADE: 22-MAR-10 MINNEAPOLIS MN 55428 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LAPORT MGB ENDOSKOPISCHE GERATE GMBH (BER510(k) NO: K092584(TRADITIONAL)
ATTN: PATRICK GAENSICKE PHONE NO : 493 063 927000 SCHWARZSCHILDSTRASSE 6 SE DECISION MADE: 22-MAR-10 BERLIN GM 12489 510(k) STATEMENT DEVICE: OPAL BOND MV ULTRADENT PRODUCTS, INC. 510(k) NO: K094006(TRADITIONAL)
ATTN: DIANE ROGERS PHONE NO : 801 553 4491 505 WEST 10200 SOUTH SE DECISION MADE: 23-MAR-10 SOUTH JORDAN UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE ANGIOSLIDE, LTD 510(k) NO: K090364(TRADITIONAL)
ATTN: ELISA HARVEY PHONE NO : 301 774 0511 18905 CELEBRITY LANE SE DECISION MADE: 23-MAR-10 SANDY SPRING MD 20860 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: D-STORM 810NM, D-STORM 980NM LIGHT INSTRUMENTS 510(k) NO: K093048(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837 31 HAAVODA ST SE DECISION MADE: 23-MAR-10 BINYAMINA IS 30500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT TAYSIDE FLOW TECHNOLOGIES LIMITED 510(k) NO: K094044(TRADITIONAL)
ATTN: RUDY MOUNIA PHONE NO : 480 518 6425 1141 E. HAWKEN WAY SE DECISION MADE: 23-MAR-10 CHANDLER AZ 85286 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ROTEM DELTA THROMBOELASTOMETRY SYSTEM PENTAPHARM GMBH 510(k) NO: K083842(TRADITIONAL)
ATTN: VOLKER JOACHIM FRIEMERT PHONE NO : 498 945 42950 STAHLGRUBERRING 12 SE DECISION MADE: 23-MAR-10 MUNICH GM D-81829 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY BERKELEY ADVANCED BIOMATERIALS, IN510(k) NO: K092046(SPECIAL)
ATTN: FRANCOIS GENIN PHONE NO : 510 883 0500 901 GRAYSON ST., SUITE 101 SE DECISION MADE: 24-MAR-10 BERKELEY CA 94710 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT HEALTHPOINT, LTD. 510(k) NO: K091890(TRADITIONAL)
ATTN: AMY CAMPBELL PHONE NO : 817 302 3901 3909 HULEN ST. SE DECISION MADE: 24-MAR-10 FORT WORTH TX 76107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 TIME MEDICAL LIMITED 510(k) NO: K093984(SPECIAL)
ATTN: DIANA HONG PHONE NO : 862 164 684973 SUITE 5D,NO.19, LANE 999 ZHONGSHANSE DECISION MADE: 24-MAR-10 SHANGHAI CH 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BONASTENT BILIARY ENDOCHOICE, INC. 510(k) NO: K093003(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 704 430 8695 1914 J.N. PEASE PLACE SE DECISION MADE: 24-MAR-10 CHARLOTTE NC 28262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MULTIPLE PRIVATE LABEL BIOGREEN YIELDS SDN.BHD 510(k) NO: K100162(TRADITIONAL)
ATTN: TIONG CHIONG KIENG PHONE NO : 605 679 2288 LOT 1422, BATU 10 LEKIR SE DECISION MADE: 24-MAR-10 SITIAWAN, PERAK MY 32020 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN HONGRAY PLASTIC PRODUCTS 510(k) NO: K100326(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 NO. 209 BEI SI HUAN ZHO SE DECISION MADE: 24-MAR-10 BEIJING CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K100186(TRADITIONAL)
ATTN: MARK JOB PHONE NO : 763 682 4139 1394 25TH STREET NW SE DECISION MADE: 24-MAR-10 BUFFALO MN 55313 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: XRES BLOOD COLLECTION RESERVOIR SORIN GROUP ITALIA S.R.L 510(k) NO: K100507(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781 434 4742 PAREXEL CONSULTING 195 WEST STREETSE DECISION MADE: 24-MAR-10 WALTHAM MA 02451 510(k) STATEMENT DEVICE: NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP LUV N' CARE, LTD. 510(k) NO: K100385(TRADITIONAL)
ATTN: JEAN ASQUITH PHONE NO : 512 327 9997 1705. S CAPITOL OF TEXAS HWY SUITESE DECISION MADE: 24-MAR-10 AUSTIN TX 78746 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO VATECH CO., LTD. 510(k) NO: K100317(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 281 598 8124 256 NORTH SAM HOUSTON PKWY E. # 11SE DECISION MADE: 24-MAR-10 HOUSTON TX 77060 510(k) STATEMENT DEVICE: INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE INCITE INNOVATION LLC 510(k) NO: K093808(TRADITIONAL)
ATTN: JOHN KIRWAN PHONE NO : 413 382 0210 1350 MAIN STREET, SUITE 1506 SE DECISION MADE: 24-MAR-10 SPRINGFIELD MA 01103 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GYNCARE MORCELLEX TISSUE MORCELLATOR ETHICON, INC. 510(k) NO: K100280(TRADITIONAL)
ATTN: BRYAN LISA PHONE NO : 908 218 3392 P.O. BOX 151 ROUTE 22 WEST SE DECISION MADE: 24-MAR-10 SOMERVILLE NJ 08876 0151 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN STERILIZATION CONTAINERS CODMAN & SHURTLEFF, INC. 510(k) NO: K092437(TRADITIONAL)
ATTN: PAUL AMARAL PHONE NO : 508 828 3393 325 PARAMOUNT DR. SE DECISION MADE: 25-MAR-10 RAYNHAM MA 02767 0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 WET NOSE TECHNOLOGIES, LLC 510(k) NO: K091538(TRADITIONAL)
ATTN: JIM BARLEY PHONE NO : 949 481 5713 3750 2ND AVE SE DECISION MADE: 25-MAR-10 LOS ANGELES CA 90018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DBB-06 HEMODIALYSIS DELIVERY SYSTEM NIKKISO CO. LTD. 510(k) NO: K091978(TRADITIONAL)
ATTN: FUMIAKI KANAI PHONE NO : 81 3 38188577 4-2-17 HONGO BUNKYO-KU SE DECISION MADE: 25-MAR-10 TOKYO JA 113-0033 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ETHICON ENDO SURGERY SLOTTED ANOSCOPE ETHICON ENDO-SURGERY, INC. 510(k) NO: K093896(TRADITIONAL)
ATTN: GLENDA MARSH PHONE NO : 513 337 7659 4545 CREEK RD. SE DECISION MADE: 25-MAR-10 CINCINNATI OH 45242 2839 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT HEALTH & LIFE CO., LTD. 510(k) NO: K093831(SPECIAL)
ATTN: SARAH SU PHONE NO : 886 282 271300 9F, NO.186, JIAN YI ROAD SE DECISION MADE: 25-MAR-10 CHUNG HO CITY, TAIPEI TW 235 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 ANGIODYNAMICS, INC. 510(k) NO: K093406(SPECIAL)
ATTN: JODI LYNN FRASIER PHONE NO : 518 798 1215 603 QUEENSBURY AVE. SE DECISION MADE: 25-MAR-10 QUEENSBURY NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAISIN PERSONAL MONITOR PROTEUS BIOMEDICAL, INC. 510(k) NO: K093976(TRADITIONAL)
ATTN: GREGORY MOON PHONE NO : 650 632 4031 2600 BRIDGE PARKWAY SUITE 101 SE DECISION MADE: 25-MAR-10 REDWOOD CITY CA 94065 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERAMIR CROWN & BRIDGE DOXA AB 510(k) NO: K100510(SPECIAL)
ATTN: MARGARETH JORVID PHONE NO : 46 70 5192640 AXEL JOHANSSONS, GATA 4-6 SE DECISION MADE: 25-MAR-10 UPPSALA SW SE-754 51 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 GENEXEL MEDICAL INSTRUMENT INC 510(k) NO: K092061(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 678 908 8180 845 ARONSON LAKE COURT SE DECISION MADE: 26-MAR-10 ROSWELL GA 30075 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION TONICA ELEKTRONIK A/S 510(k) NO: K091940(TRADITIONAL)
ATTN: LISE TERKELSEN PHONE NO : 454 499 8444 LUCERNEMARKEN 15 SE DECISION MADE: 26-MAR-10 FARUM DA 3520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MOVES THORNHILL RESEARCH INC 510(k) NO: K093261(TRADITIONAL)
ATTN: CLIFF ANSEL PHONE NO : 416 597 1325 70 PETER ST. 2ND FL. SE DECISION MADE: 26-MAR-10 TORONTO, ONTARIO CA M5V 2G5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K093941(SPECIAL)
ATTN: DEBRA LIANG PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD WUGU TOSE DECISION MADE: 26-MAR-10 TAIPEI COUNTY TW 248 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INDUS ANTERIOR CERVICAL PLATE SYSTEM SPINEFRONTIER, INC. 510(k) NO: K093776(TRADITIONAL)
ATTN: JOHN SULLIVAN PHONE NO : 978 232 3990 500 CUMMINGS CENTER, STE. 3500 SE DECISION MADE: 26-MAR-10 BEVERLY MA 01915 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFILTRATION KIT DMG USA, INC. 510(k) NO: K100062(ABBREVIATED)
ATTN: PAMELA PAPINEAU PHONE NO : 978 772 3552 23 FRANK MOSSBERG DRIVE SE DECISION MADE: 26-MAR-10 ATTLEBORO MA 02703 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIVIT A/B ST AND PIVIT A/B ST-R TYRX ,INC 510(k) NO: K093524(TRADITIONAL)
ATTN: MARK CITRON PHONE NO : 732 246 8676 1 DEER PARK DRIVE SUITE G SE DECISION MADE: 26-MAR-10 MONMOUTH JUNCTION NJ 08852 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: G-FORCE TI SUTURE ANCHOR SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K100579(SPECIAL)
ATTN: KELLEN HILLS PHONE NO : 901 290 5816 5677 AIRLINE RD. SE DECISION MADE: 26-MAR-10 ARLINGTON TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HOVEROUND TEKNIQUE, MODEL HD-6 HOVEROUND CORP. 510(k) NO: K100527(SPECIAL)
ATTN: TONY DIGIOVANNI PHONE NO : 941 739 6200 2151 WHITFIELD INDUSTRIAL WAY SE DECISION MADE: 26-MAR-10 SARASOTA FL 34243 510(k) STATEMENT DEVICE: TORQMAX SHEATH GRIP ACCESSORY SPECTRANETICS CORP. 510(k) NO: K093257(TRADITIONAL) ATTN: BRANDON HANSEN PHONE NO : 719 447 2385 9665 FEDERAL DRIVE SE DECISION MADE: 26-MAR-10 COLORADO SPRINGS CO 80921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STAIR SYSTEMS PACS & DICOM VIEWER STAIR SYSTEMS, INC. 510(k) NO: K100236(TRADITIONAL)
ATTN: JAMES W MONROE PHONE NO : 484 894 4921 747 CEDARD HILL DRIVE SE DECISION MADE: 29-MAR-10 ALLENTOWN PA 18109 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOPLEX 2200 MMRV IGG BIO-RAD LABORATORIES 510(k) NO: K091616(TRADITIONAL)
ATTN: DAVID BHEND PHONE NO : 425 881 8300 6565 185TH AVE, NE SE DECISION MADE: 29-MAR-10 REDMOND WA 98052 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM GPC MEDICAL LTD 510(k) NO: K092493(TRADITIONAL)
ATTN: VIKAS NARANG PHONE NO : 911 145 545151 G-3 VIKAS PURI SE DECISION MADE: 29-MAR-10 NEW DELPHI IN 110018 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ELECSYS CK-MB CALCHECK 5 ROCHE DIAGNOSTICS 510(k) NO: K093582(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317 521 3225 9115 HAGUE ROAD SE DECISION MADE: 29-MAR-10 INDIANAPOLIS IN 46250 510(k) STATEMENT DEVICE: SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES SYNTHES (USA) 510(k) NO: K093928(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610 719 6941 1301 GOSHEN PKWY. SE DECISION MADE: 29-MAR-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES STERNAL FIXATION SYSTEM SYNTHES 510(k) NO: K093772(TRADITIONAL)
ATTN: ANDREA M TASKER PHONE NO : 610 719 6290 1301 GOSHEN PARKWAY SE DECISION MADE: 29-MAR-10 WEST CHESTER PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN HENGTONG PLASTIC PRODUCTS510(k) NO: K100324(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 JIANXIANG YUAN NO. 209 BEI SI HUASE DECISION MADE: 29-MAR-10 CHU XIAOAN CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES TANGSHAN QIXIN GLOVE CO., LTD. 510(k) NO: K100337(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441 JIANXIANG YUAN NO. 209 BEI SI HUANSE DECISION MADE: 29-MAR-10 CHU XIAOAN CH 100083 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTISAN AESTHETIC SYSTEM PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K100270(TRADITIONAL)
ATTN: SHARON TIMBERLAKE, MSHS, RAPHONE NO : 781 993 2414 15 NETWORK DRIVE SE DECISION MADE: 29-MAR-10 BURLINGTON MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TELAVANCIN 30 UG, BBL SENSI-DISC BECTON, DICKINSON AND COMPANY 510(k) NO: K100722(TRADITIONAL)
ATTN: JANINE SPAFFORD PHONE NO : 410 316 4938 7 LOVETON CIRCLE, MC 614 SE DECISION MADE: 29-MAR-10 SPARKS MD 21152 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK OMNI LIFE SCIENCE, INC. 510(k) NO: K100555(SPECIAL)
ATTN: RADHIKA PONDICHERRY PHONE NO : 774 226 1852 50 O'CONNELL WAY SE DECISION MADE: 29-MAR-10 EAST TAUNTON MA 02718 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM PATHFINDER THERAPEUTICS, INC. 510(k) NO: K093494(SPECIAL)
ATTN: CRAIG HENDERSON PHONE NO : 615 783 0094 2969 ARMORY DRIVE SUITE 100A SE DECISION MADE: 30-MAR-10 NASHVILLE TN 37204 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) RELIEVANT MEDSYSTEMS 510(k) NO: K100641(SPECIAL)
ATTN: ADAM SAVAKUS PHONE NO : 650 368 1000 2688 MIDDLEFIELD ROAD, SUITE A SE DECISION MADE: 30-MAR-10 REDWOOD CITY CA 94063 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYSMEX MODEL XT-4000I SYSMEX AMERICA, INC. 510(k) NO: K091313(TRADITIONAL)
ATTN: SHARITA BROOKS PHONE NO : 847 996 4618 ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 30-MAR-10 MUNDELEIN IL 60060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 HIVOX BIOTEK, INC. 510(k) NO: K092448(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 285 112668 8 F.,NO. 98, SHINDE RD., SANCHONG SE DECISION MADE: 30-MAR-10 TAIPEI HSIEN TW 24158 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER EPOCAL, INC. 510(k) NO: K092849(TRADITIONAL)
ATTN: ROY LAYER PHONE NO : 613 738 6192 2060 WALKLEY RD. SE DECISION MADE: 30-MAR-10 OTTAWA, ONTARIO CA K1G-3P5 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE DRAEGER MEDICAL AG & CO. KG 510(k) NO: K093633(TRADITIONAL)
ATTN: JOYCE KILROY PHONE NO : 215 660 2626 3135 QUARRY ROAD SE DECISION MADE: 30-MAR-10 TELFORD PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE BOSTON SCIENTIFIC CORPORATION 510(k) NO: K100712(TRADITIONAL)
ATTN: ASHLEY PYLE PHONE NO : 508 281 2163 100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 30-MAR-10 MARLBOROUGH MA 01752 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM INTERLACE MEDICAL INC. 510(k) NO: K100559(SPECIAL)
ATTN: JOHN VOZELLA PHONE NO : 508 875 1343 135 NEWBURY ST SE DECISION MADE: 30-MAR-10 FRAMINGHAM MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARSTASIS ACCESS SYSTEM ARSTASIS, INC. 510(k) NO: K100615(SPECIAL)
ATTN: SU-MIEN CHONG PHONE NO : 650 704 1632 1021 HOWARD AVE SUITE C SE DECISION MADE: 30-MAR-10 SAN CARLOS CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC 510(k) NO: K100671(SPECIAL)
ATTN: DAVID M GAISSER PHONE NO : 386 462 7660 13631 PROGRESS BLVD SUITE 600 SE DECISION MADE: 30-MAR-10 ALACHUA FL 32615 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITAL SIGNS MONITOR SHENZHEN CREATIVE INDUSTRY CO., LT510(k) NO: K093016(TRADITIONAL) ATTN: CHARLIE MACK PHONE NO : 931 625 4938 77325 JOYCE WAY SE DECISION MADE: 30-MAR-10 ECHO OR 97826 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM HU-FRIEDY MFG. CO., INC 510(k) NO: K100401(TRADITIONAL)
ATTN: MARIA VRABIE PHONE NO : 773 975 3975 3232 N. ROCKWELL STREET SE DECISION MADE: 30-MAR-10 CHICAGO IL 60618 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HANDHELD ECG MONITOR, MODEL MD100 BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K093872(TRADITIONAL)
ATTN: YAJING LI PHONE NO : 86 10 88790480 NO. 9 SHUANGYUAN RD. SHIJINGSHAN DSE DECISION MADE: 31-MAR-10 BEIJING CH 100041 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMNS MEDACTA NAVIGATION SYSTEM,33.221000US MEDACTA INTERNATIONAL, SA 510(k) NO: K100314(SPECIAL)
ATTN: HEATHER NEELY PHONE NO : 805 886 1069 4725 CALLE QUETZAL SUITE B SE DECISION MADE: 31-MAR-10 CAMARILLO CA 93012 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LDR SPINE USA SPINE TUNE TL SPINE SYSTEM LDR SPINE USA 510(k) NO: K100575(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512 344 3319 4030 WEST BRAKER LANE SUITE 360 SE DECISION MADE: 31-MAR-10 AUSTIN TX 78759 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 273 TOTAL WITH SUMMARIES 240 TOTAL WITH STATEMENTS 33
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