SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-JAN-2008 THROUGH 31-JAN-2008 DEVICE: TEMPXN28 3M ESPE AG DENTAL PRODUCTS 510(k) NO: K073296(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 011 498 1527001169 ESPE PLATZ SE DECISION MADE: 09-JAN-08 SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GILB-2, GLASS IONOMER PROTECTIVE COATING 3M ESPE DENTAL PRODUCTS 510(k) NO: K073395(TRADITIONAL)
ATTN: KAREN O'MALLEY PHONE NO : 651-736-7326 3M CENTER; BLDG 260-2A-17 SE DECISION MADE: 17-JAN-08 ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3VISEON/SURGERY 3MENSIO MEDICAL IMAGING BV 510(k) NO: K072653(TRADITIONAL)
ATTN: CARL THOMAS PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 24-JAN-08 DENTON, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INSUCOZI INSULIN VIAL COVER 41 INDUSTRIES LLC 510(k) NO: K072174(TRADITIONAL) ATTN: DANIEL LAFAVER PHONE NO : 303-916-2110 4220 BALSAM STREET SE DECISION MADE: 25-JAN-08 WHEAT RIDGE, CO 80033 510(k) STATEMENT DEVICE: AVIATOR INSULIN PUMP ABBOTT DIABETES CARE INC. 510(k) NO: K071788(TRADITIONAL)
ATTN: SARAH HARRINGTON PHONE NO : 510-239-2732 1360 SOUTH LOOP RD. SE DECISION MADE: 11-JAN-08 ALAMEDA, CA 94502-7000 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARDIS SPACER ABBOTT SPINE, INC. 510(k) NO: K073202(TRADITIONAL)
ATTN: MARITZA ELIAS PHONE NO : 512-533-1908 5301 RIATA PARK CT., BLDG F SE DECISION MADE: 30-JAN-08 AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER ABBOTT VASCULAR-VASCULAR SOLUTIONS510(k) NO: K072798(TRADITIONAL)
ATTN: DANIELLE M TAYLOR PHONE NO : 408-845-0883 3200 LAKESIDE DR. SE DECISION MADE: 31-JAN-08 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCIN HIP SYSTEM ACCELERATED INNOVATION, LLC 510(k) NO: K073068(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 973-777-8832 1033 US HIGHWAY 46 EAST SE DECISION MADE: 10-JAN-08 SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA CLIFTON, NJ 07013 DEVICE: ACCIN ANTERIOR CERVICAL PLATE SYSTEM ACCELERATED INNOVATION, LLC 510(k) NO: K073530(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 973-777-8832 1033 US HIGHWAY 46 EAST SE DECISION MADE: 31-JAN-08 SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA CLIFTON, NJ 07013 DEVICE: VEINOPLUS NEUROMUSCULAR STIMULATOR ADREM TECHNOLOGY SARL 510(k) NO: K072252(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899 9109 COPENHAVER DRIVE SE DECISION MADE: 30-JAN-08 POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHOGLIDE LATERAL KNEE IMPLANT AND INSTRUMENTS ADVANCED BIO-SURFACES, INC. 510(k) NO: K073233(TRADITIONAL)
ATTN: PHILIP B JARVI PHONE NO : 952-979-1804 14289 YELLOW PINE STREET SE DECISION MADE: 28-JAN-08 ANDOVER, MN 55345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE ADVANCED SURGICAL CONCEPTS 510(k) NO: K073719(SPECIAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 29-JAN-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WAVESENSE KEYNOTE CODELESS BLOOD GLUCOSE MONITORING SYSTEM AGAMATRIX 510(k) NO: K073573(SPECIAL)
ATTN: CONNIE HERTEL PHONE NO : 603-328-6051 10 MAOR PARKWAY SE DECISION MADE: 30-JAN-08 SALEM, NH 03079 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGISTRATION AND FUSION AGFA HEALTHCARE CORPORATION 510(k) NO: K080013(TRADITIONAL)
ATTN: TOM HOLBROOK PHONE NO : 519-746-6210 10 SOUTH ACADEMY STREET SE DECISION MADE: 17-JAN-08 GREENVILLE, SC 29601 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: RESUSCITATION TIMER, MODEL L770-CPR ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K073171(TRADITIONAL) ATTN: WAYNE KARCHER PHONE NO : 314-771-2400 1720 SUBLETTE AVE. SE DECISION MADE: 31-JAN-08 ST. LOUIS, MO 63110 510(k) STATEMENT DEVICE: ALN OPTIONAL VENA CAVA FILTER-FEMORAL APPROACH, JUGULAR APPROACH ALN IMPLANTS CHIRURGICAUX 510(k) NO: K070514(ABBREVIATED)
ATTN: DAVE PARENTE PHONE NO : 770-563-7665 900 CIRCLE 75 PKWY. SE DECISION MADE: 30-JAN-08 SUITE 1240 510(k) SUMMARY AVAILABLE FROM FDA ATLANTA, GA 30339 DEVICE: G-TRAINER MEDICAL ALTER-G, INC. 510(k) NO: K072887(TRADITIONAL)
ATTN: GLEN MANGSETH PHONE NO : 650-289-9444 1090A O'BRIEN DRIVE SE DECISION MADE: 25-JAN-08 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFE+CEL OR LIFECEL BATTERY PACK, MODEL 5L500 AMCO INTERNATIONAL MANUFACTURING &510(k) NO: K072596(TRADITIONAL)
ATTN: ALEXANDER B HENDERSON PHONE NO : 303-646-3715 377 ZANE CT. SE DECISION MADE: 24-JAN-08 ELIZABETH, CO 80107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VALEO PEDICLE SCREW SPINAL SYSTEM AMEDICA CORP. 510(k) NO: K073430(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202-552-5800 1331 H ST. NW, 12TH FLOOR SE DECISION MADE: 29-JAN-08 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VALEO VBR AMEDICA CORP. 510(k) NO: K073505(SPECIAL)
ATTN: ADAM HERDER PHONE NO : 202-552-5800 1331 H ST. NW, 12TH FLOOR SE DECISION MADE: 09-JAN-08 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS MINIARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K073703(SPECIAL)
ATTN: BRAD ONSTAD PHONE NO : 952-930-6139 10700 BREN RD., WEST SE DECISION MADE: 30-JAN-08 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIODYNAMICS, INC., NEVERTOUCH II 400UM FIBER AND VENACURE PROC ANGIODYNAMICS, INC. 510(k) NO: K073464(SPECIAL)
ATTN: TERI JUCKETT PHONE NO : 518-798-1215 603 QUEENSBURY AVE. SE DECISION MADE: 23-JAN-08 QUEENSBURY, NY 12804 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SKATER BILIARY CATHETER ANGIOTECH 510(k) NO: K073672(SPECIAL)
ATTN: TRUDY ESTRIDGE PHONE NO : 650-245-6561 13921 PARK CENTER ROAD SE DECISION MADE: 24-JAN-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA HERNDON, VA 20171 DEVICE: MODIFICATION TO: ARAGON SURGICAL LAPCAP ARAGON SURGICAL INC. 510(k) NO: K073452(SPECIAL)
ATTN: ALAN CURTIS PHONE NO : 650-543-3107 1810 EMBARCADERO ROAD, SUITE B SE DECISION MADE: 11-JAN-08 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTUITION, MODEL 0170 ARCOMA AB 510(k) NO: K073632(TRADITIONAL)
ATTN: BENGT-HUGO JOHANSSON PHONE NO : 46 470 706900 ANNAVAGEN 1 SE DECISION MADE: 10-JAN-08 VAXJO, SWEDEN S-352 46 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PRESSURE INJECTABLE PICC ARROW INTERNATIONAL, INC. 510(k) NO: K073451(SPECIAL)
ATTN: KEVIN LENTZ PHONE NO : 610-378-0131 2400 BERNVILLE RD. SE DECISION MADE: 15-JAN-08 READING, PA 19605 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT ARTHREX, INC. 510(k) NO: K071456(TRADITIONAL)
ATTN: MARIELA CABARCAS PHONE NO : 239-643-5553 1370 CREEKSIDE BLVD. SE DECISION MADE: 17-JAN-08 NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ASAHI PTCA GUIDE WIRE ASAHI INTECC CO., LTD. 510(k) NO: K070945(SPECIAL)
ATTN: YOSHI TERAI PHONE NO : 949-756-8252 2500 RED HILL SUITE 210 SE DECISION MADE: 09-JAN-08 SANTA ANA,, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN AUTOGENOMICS, INCORPORATED 510(k) NO: K073014(ABBREVIATED)
ATTN: EVELYN G LOPEZ PHONE NO : 760-804-7378 2251 RUTHERFORD ROAD SE DECISION MADE: 23-JAN-08 CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AXENIC DHP DISPOSABLE HIGH-PERFORMANCE HANDPIECE AXENIC DENTAL, INC. 510(k) NO: K072754(TRADITIONAL)
ATTN: JOSEPH T SOBOTA PHONE NO : 269-349-8870 259 EAST MICHIGAN AVE. SE DECISION MADE: 25-JAN-08 SUITE 409 510(k) SUMMARY AVAILABLE FROM FDA KALAMAZOO, MI 49007 DEVICE: SOLCART B B. BRAUN MEDIZINTECHNOLOGIE GMBH 510(k) NO: K072760(TRADITIONAL)
ATTN: TRACY MADDOCK PHONE NO : 610-596-2240 901 MARCON BOULEVARD SE DECISION MADE: 29-JAN-08 ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NIO 5MP DISPLAY, MODEL E5620 BARCOVIEW, MEDICAL IMAGING SYSTEMS510(k) NO: K072875(TRADITIONAL) ATTN: NEIL PHILLIPS PHONE NO : 441 314 725721 35 PRESIDENT KENNEDYPARK SE DECISION MADE: 22-JAN-08 KORTRIJK, BELGIUM B-8500 510(k) STATEMENT DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 BECTON, DICKINSON & CO. 510(k) NO: K073433(TRADITIONAL)
ATTN: VICKI K WHITLEY PHONE NO : 410-316-4161 7 LOVETON CIR. SE DECISION MADE: 14-JAN-08 SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FINGERTIP PULSE OXIMETER, MODEL MD300I BEIJING CHOICE ELECTRONIC TECHNOLO510(k) NO: K072825(SPECIAL)
ATTN: DIANA HONG PHONE NO : 86 216 4264467 SUITE 8D, ZHONGXIN ZHONGSHAN SE DECISION MADE: 14-JAN-08 NO19, LN999, ZHONG SHAN NAN ER 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 DEVICE: QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 BIO-RAD LABORATORIES 510(k) NO: K073080(TRADITIONAL)
ATTN: MARIA ZEBALLOS PHONE NO : 949-598-1367 9500 JERONIMO RD. SE DECISION MADE: 24-JAN-08 IRVINE, CA 92618-2017 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GELSPRAY WOUND DRESSING BIOCURE, INC. 510(k) NO: K073663(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548 20310 SW 48TH STREET SE DECISION MADE: 30-JAN-08 SOUTHWEST RANCHES, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLYCERIN & PARABEN FREE ASTROGLIDE BIOFILM, INC. 510(k) NO: K072647(TRADITIONAL)
ATTN: ROBERT DE ARMOND PHONE NO : 760-727-9030 3225 EXECUTIVE RIDGE SE DECISION MADE: 25-JAN-08 VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WATERLASE MD DERM BIOLASE TECHNOLOGY, INC. 510(k) NO: K071734(TRADITIONAL)
ATTN: IOANA RIZOIU PHONE NO : 949-226-8144 4 CROMWELL SE DECISION MADE: 25-JAN-08 IRVINE, CA 92618-1816 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC. 510(k) NO: K072779(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST., NW SE DECISION MADE: 24-JAN-08 WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE BIOMERIEUX, INC. 510(k) NO: K073406(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695 595 ANGLUM RD. SE DECISION MADE: 23-JAN-08 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX BIOMET 3I, INC. 510(k) NO: K072363(TRADITIONAL)
ATTN: DIANA TAYLOR PHONE NO : 561-776-6857 4555 RIVERSIDE DR. SE DECISION MADE: 31-JAN-08 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNERVUE DIAGNOSTIC SCOPE SYSTEM BIOMET ORTHOPEDICS, INC. 510(k) NO: K072879(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639 56 EAST BELL DR. SE DECISION MADE: 14-JAN-08 P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA WARSAW, IN 46581-0587 DEVICE: BIPORE BALLOON DILATION CATHETER BIPORE, INC. 510(k) NO: K073318(SPECIAL) ATTN: KEITH PALUCH PHONE NO : 201-767-1993 31 INDUSTRIAL PKWY. SE DECISION MADE: 16-JAN-08 NORTHVALE, NJ 07647 510(k) STATEMENT DEVICE: BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS BLACK & BLACK SURGICAL, INC. 510(k) NO: K072124(TRADITIONAL)
ATTN: NORMAN M BLACK, III PHONE NO : 404-428-1813 2759 HAWTHORNE DR. SE DECISION MADE: 18-JAN-08 ATLANTA, GA 30345 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BLACKSTONE ASCENT POCT SYSTEM PARALLEL ROD CONNECTOR BLACKSTONE MEDICAL, INC. 510(k) NO: K073654(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838 1211 HAMBURG TURNPIKE SE DECISION MADE: 24-JAN-08 SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA WAYNE, NJ 07470 DEVICE: BOSTON-BAND CRANIAL REMODLING ORTHOSIS BOSTON BRACE INTL., INC. 510(k) NO: K072862(SPECIAL)
ATTN: JAMES H WYNNE PHONE NO : 508-588-1144 20 LEDIN DR. SE DECISION MADE: 22-JAN-08 AVON, MA 02322 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HE BRAINLAB AG 510(k) NO: K073018(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 49 89 9915680 KAPELLENSTRASSE 12 SE DECISION MADE: 23-JAN-08 FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPS COURIER GUIDEWIRE BRIVANT, LTD. 510(k) NO: K073082(SPECIAL)
ATTN: TOMAS FUREY PHONE NO : 353 91 385037 PARKMORE WEST BUSINESS PARK SE DECISION MADE: 09-JAN-08 GALWAY, COUNTY GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; C.R. BARD, INC. 510(k) NO: K073090(TRADITIONAL)
ATTN: GENEVIEVE BALUTOWSKI PHONE NO : 480-379-2524 PO BOX 1740 SE DECISION MADE: 15-JAN-08 1625 WEST 3RD STREET 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85281-1740 DEVICE: VACCESS PTA BALLOON DILATATION CATHETER C.R. BARD, INC. 510(k) NO: K073472(SPECIAL)
ATTN: JENNIFER LOGVIN PHONE NO : 480-303-2752 1625 WEST 3RD ST. SE DECISION MADE: 09-JAN-08 P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA TEMPE, AZ 85281-1740 DEVICE: CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B CAREMATIX INC. 510(k) NO: K073038(SPECIAL)
ATTN: SUKHWANT KHANUJA PHONE NO : 312-627-9300 120 S. RIVERSIDE PLAZA SE DECISION MADE: 11-JAN-08 SUITE 2100 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60606 DEVICE: PROVISA CEM CAVEX HOLLAND B.V. 510(k) NO: K073539(TRADITIONAL)
ATTN: RICHARD WOORTMAN PHONE NO : 011 31 235307763 PO BOX 852 SE DECISION MADE: 31-JAN-08 HAARLEM (HOLLAND), NETHERLANDS 200510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTERAL FEEDING SPIKE ADAPTER CEDIC S.R.L. 510(k) NO: K072652(TRADITIONAL)
ATTN: GIANCARLO GAGLIARDONI PHONE NO : 390 255 300174 VIA LIBERAZIONE, 63/9 SE DECISION MADE: 18-JAN-08 PESCHIERA BORROMEO MILAN(LOMB), IT510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NICOM ELECTRODES CHEETAH MEDICAL INC. 510(k) NO: K071631(TRADITIONAL)
ATTN: RHONA SHANKER PHONE NO : 301-251-9570 12154 DARNESTOWN RD. #236 SE DECISION MADE: 18-JAN-08 GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHEETAH RELIANT, CHEETAH ACTIVE CHEETAH MEDICAL INC. 510(k) NO: K072662(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 499 40337 INDUSTRIAL PARK 13 SE DECISION MADE: 16-JAN-08 MIZPE AVIV, M.P. MISGAV, ISRAEL 20510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES CIBA VISION CORPORATION 510(k) NO: K072777(TRADITIONAL)
ATTN: MARTINA HEIM PHONE NO : 678-415-3565 11460 JOHNS CREEK PARKWAY SE DECISION MADE: 24-JAN-08 DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 CODMAN & SHURTLEFF, INC. 510(k) NO: K073336(SPECIAL) ATTN: EMILY E VALERIO PHONE NO : 508-828-3038 325 PARAMOUNT DR. SE DECISION MADE: 04-JAN-08 RAYNHAM, MA 02767-0350 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008 CONFLUENT SURGICAL,INC 510(k) NO: K072790(TRADITIONAL)
ATTN: VIRGINIA VETTER PHONE NO : 781-839-1755 101A FIRST AVE. SE DECISION MADE: 11-JAN-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THREVO ANCHOR, DISPOSABLE DRIVER, HI-FI SUTURES CONMED LINVATEC 510(k) NO: K073481(SPECIAL)
ATTN: JOY LOVETT PHONE NO : 727-399-5137 11311 CONCEPT BOULEVARD SE DECISION MADE: 07-JAN-08 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OPTILITE HOLMIUM LASER FIBERS COOK UROLOGICAL, INC. 510(k) NO: K073496(TRADITIONAL)
ATTN: CINDY FOOTE PHONE NO : 812-829-4891 1100 WEST MORGAN ST. SE DECISION MADE: 23-JAN-08 SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPH COOPERSURGICAL, INC. 510(k) NO: K063223(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320 543 LONG HILL AVE. SE DECISION MADE: 23-JAN-08 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC. 510(k) NO: K071736(TRADITIONAL)
ATTN: JACK P DOUGLAS PHONE NO : 925-621-2452 6140 STONERIDGE MALL ROAD SE DECISION MADE: 04-JAN-08 SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA PLEASANTON, CA 94588 DEVICE: I-PAD CU MEDICAL SYSTEMS, INC. 510(k) NO: K062970(TRADITIONAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035 P.O. BOX 560 SE DECISION MADE: 22-JAN-08 STILLWATER, MN 55082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IPULSE, QUADRA Q4 PLATINUM SERIES, MODEL(S) 1200+SERIES 2, 1300 CYDEN LIMITED 510(k) NO: K071883(SPECIAL) ATTN: MICHAEL KIERNAN PHONE NO : 441 792 485682 TECHNIUM 1, KINGS ROAD SE DECISION MADE: 23-JAN-08 SWANSEA, WALES, UNITED KINGDOM SA1510(k) STATEMENT DEVICE: CYNOSURE SMARTLIPO MULTIWAVLENGTH LASER CYNOSURE, INC. 510(k) NO: K080121(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200 5 CARLISLE ROAD SE DECISION MADE: 31-JAN-08 WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOFTPAP CERVICAL CELL COLLECTOR CYTOCORE, INC. 510(k) NO: K072381(SPECIAL)
ATTN: RICHARD DOMANIK PHONE NO : 312-222-9550 414 NORTH ORLEAN SE DECISION MADE: 30-JAN-08 SUITE 502 510(k) SUMMARY AVAILABLE FROM FDA CHICAGO, IL 60610 DEVICE: CYTOPHIL TISSUE MARKER CYTOPHIL INC 510(k) NO: K072219(TRADITIONAL)
ATTN: GREG JOHNSON PHONE NO : 414-961-7372 5546 N SANTA MONICA BLVD SE DECISION MADE: 18-JAN-08 WHITEFISH BAY, WI 53217-5159 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMAPAL WITH DIGITAL TIMER DAAVLIN DISTRIBUTING CO. 510(k) NO: K073587(TRADITIONAL)
ATTN: TARA MANSUR PHONE NO : 419-636-6304 205 WEST BEMENT ST. SE DECISION MADE: 18-JAN-08 BRYAN, OH 43506 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DADE BEHRING, INC. 510(k) NO: K073055(TRADITIONAL)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376 P.O. BOX 6101 SE DECISION MADE: 03-JAN-08 MS 514 510(k) SUMMARY AVAILABLE FROM FDA NEWARK, DE 19714 DEVICE: DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 DANE TECHNOLOGIES 510(k) NO: K073701(TRADITIONAL)
ATTN: OLIVER PITTENGER PHONE NO : 763-746-4423 7105 NORTHLAND TERRACE SE DECISION MADE: 28-JAN-08 BROOKLYN PARK, MN 55428 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC. 510(k) NO: K073707(SPECIAL) ATTN: DAN KOSEDNAR PHONE NO : 608-221-1551 PO BOX 7550 SE DECISION MADE: 30-JAN-08 MADISON, WI 53707 510(k) STATEMENT DEVICE: PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400 DELPHI MEDICAL SYSTEMS 510(k) NO: K073242(TRADITIONAL)
ATTN: GILBERT ROQUE PHONE NO : 248-813-2373 5725 DELPHI DRIVE SE DECISION MADE: 03-JAN-08 TROY, MI 48098 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: AURAVENEER CEMENT DENALI CORPORATION 510(k) NO: K073101(TRADITIONAL)
ATTN: JAN G STANNARD PHONE NO : 781-826-9190 134 OLD WASHINGTON STREET SE DECISION MADE: 17-JAN-08 HANOVER, MA 02339 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SELF-ADHESIVE RESIN CEMENT DENTSPLY INTERNTIONAL 510(k) NO: K073173(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 23-JAN-08 SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: MTA ADVANCED MATERIAL DENTSPLY INTERNTIONAL 510(k) NO: K073218(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 07-JAN-08 SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: AXIS SYSTEM DENTSPLY INTL., INC. 510(k) NO: K072989(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 SUSQUEHANNA COMMERCE CENTER SE DECISION MADE: 28-JAN-08 221 W PHILADELPHIA ST. STE 60 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: DEPALT VAGINAL SPECUIM AND DEPALT LIGHTING SYSTEM DEPALT INC. 510(k) NO: K072762(TRADITIONAL)
ATTN: RAJEEV PATEL PHONE NO : 469-688-2351 5013 STONEWICK COURT SE DECISION MADE: 22-JAN-08 PLANO, TX 75093 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRYPHON BR AND HEALIX BR ANCHORS DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K073412(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988 325 PARAMOUNT DR. SE DECISION MADE: 17-JAN-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY PINNACLE ALTRX ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K072963(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 09-JAN-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY ASR 300 ACETABULAR CUP SYSTEM DEPUY ORTHOPAEDICS, INC. 510(k) NO: K073413(SPECIAL)
ATTN: DAWN SINCLAIR PHONE NO : 574-371-4906 700 ORTHOPAEDIC DR. SE DECISION MADE: 30-JAN-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY SIGMA PS FEMORAL COMPONENTS DEPUY ORTHOPAEDICS, INC. 510(k) NO: K073529(SPECIAL)
ATTN: NANCY FRIDDLE PHONE NO : 574-371-4923 700 ORTHOPAEDIC DR. SE DECISION MADE: 24-JAN-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP DEPUY ORTHOPAEDICS, INC. 510(k) NO: K073676(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927 700 ORTHOPAEDIC DR. SE DECISION MADE: 29-JAN-08 WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BENGAL STACKABLE CAGE SYSTEM DEPUY SPINE, INC. 510(k) NO: K073649(SPECIAL)
ATTN: SHARON SLAROWICZ PHONE NO : 508-828-2867 325 PARAMOUNT DR. SE DECISION MADE: 25-JAN-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HEARTEVENT, MODEL AT DIAGNOSTIC DEVICES PTY LTD 510(k) NO: K072385(TRADITIONAL)
ATTN: HARRY PLATT PHONE NO : 203 654 7093 SUITE 405 OFFICE TOWER SE DECISION MADE: 11-JAN-08 WESTFIELD EASTGARDENS 510(k) SUMMARY AVAILABLE FROM FDA EASTGARDENS, AUSTRALIA 2036 DEVICE: DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLS DIAZYME LABORATORIES 510(k) NO: K072395(TRADITIONAL)
ATTN: CHARLES YU PHONE NO : 858-455-4761 12889 GREGG COURT SE DECISION MADE: 03-JAN-08 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGIFLO CONCENTRATOR ANALYZER DIGIFLO, INC. 510(k) NO: K072469(TRADITIONAL)
ATTN: MIKE STERN PHONE NO : 206-232-2193 6942 96TH AVE. SE SE DECISION MADE: 03-JAN-08 MERCER ISLAND, WA 98040 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS DIMA ITALIA SRL 510(k) NO: K072292(TRADITIONAL)
ATTN: LEWIS WARD PHONE NO : 303-530-3279 4655 KIRKWOOD CT. SE DECISION MADE: 07-JAN-08 BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VERSA LITE DIOMEDICS, INC. 510(k) NO: K073503(TRADITIONAL) ATTN: GARY MOCNIK PHONE NO : 949-433-0413 24372 MCCLOUD CT. SE DECISION MADE: 23-JAN-08 LAGUNA NIGUEL, CA 92677 510(k) STATEMENT DEVICE: FILTER CARESTAR 30; FILTER SAFESTAR 55; FILTER/HME TWINSTAR 55 DRAEGER MEDICAL AG & CO. KG 510(k) NO: K072002(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 215-660-2078 3135 QUARRY ROAD SE DECISION MADE: 31-JAN-08 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFINITY PICCO POD, MODEL MS16734 DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K073113(TRADITIONAL)
ATTN: GENCI OMARI PHONE NO : 978-379-8219 6 TECH DRIVE SE DECISION MADE: 03-JAN-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPRO DRG INTL., INC. 510(k) NO: K062534(TRADITIONAL) ATTN: GARY LEHNUS PHONE NO : 570-620-0198 150 CHERRY LANE RD. SE DECISION MADE: 29-JAN-08 EAST STROUDSBURG, PA 18301 510(k) STATEMENT DEVICE: FLAATZ 750 DRTECH CORP. 510(k) NO: K080064(TRADITIONAL) ATTN: BEOM-JIN MOON PHONE NO : 82 31 7306804 333-1, SANGDEAWON 1-DONG SE DECISION MADE: 23-JAN-08 JUNGWON-GU 510(k) STATEMENT SEONGNAM-SHI, GYEONGGI-DO, REPUBLITHIRD PARTY REVIEW DEVICE: PORTABLE ECSCOPE 12I DYANSYS, INC. 510(k) NO: K080036(TRADITIONAL)
ATTN: SRINI NAGESHWAR PHONE NO : 408-354-8447 577 AIRPORT BLVD. SUITE 610 SE DECISION MADE: 16-JAN-08 BURLINGAME, CA 95032 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PE EDWARDS LIFESCIENCES RESEARCH MEDI510(k) NO: K073559(SPECIAL)
ATTN: JOHN W NICHOLSON PHONE NO : 801-565-6282 6864 SOUTH 300 WEST SE DECISION MADE: 31-JAN-08 MIDVALE, UT 84047 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM ELITE SURGICAL SUPPLIES (PTY) LTD.510(k) NO: K080075(SPECIAL)
ATTN: CHARISE DE BARROS PHONE NO : 404-408-2396 503 COMMERCE PARK DRIVE SE DECISION MADE: 28-JAN-08 SUITE 1 510(k) SUMMARY AVAILABLE FROM FDA MARIETTA, GA 30060 DEVICE: HABIB LAPAROSCOPIC HEXABLATE EMCISION, LTD. 510(k) NO: K073687(TRADITIONAL)
ATTN: NAGY HABIB PHONE NO : 020 838 32273 DU CANE ROAD SE DECISION MADE: 09-JAN-08 LONDON, UNITED KINGDOM W12 0NN 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: REVELATION AND LINEAR HIP STEMS AND FMP ACETABULAR SHELLS (SPIKE ENCORE MEDICAL, L.P. 510(k) NO: K072888(SPECIAL)
ATTN: TIFFANY HUTTO PHONE NO : 512-834-6255 9800 METRIC BLVD. SE DECISION MADE: 10-JAN-08 AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYST ENDIUS, INC. 510(k) NO: K073267(TRADITIONAL)
ATTN: REGINA WAGNER PHONE NO : 508-643-0983 23 WEST BACON ST. SE DECISION MADE: 30-JAN-08 PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VASCUVIEW ULTRASOUND SYSTEM ESCALON MEDICAL CORP. 510(k) NO: K080049(TRADITIONAL)
ATTN: MARK WALLACE PHONE NO : 414-745-7870 2440 SOUTH 179TH ST. SE DECISION MADE: 23-JAN-08 NEW BERLIN, WI 53146 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VEN EVENT MEDICAL, INC. 510(k) NO: K072590(TRADITIONAL)
ATTN: ROBERT LUNDBERG PHONE NO : 949-360-8368 81 COLUMBIA, SUITE 101 SE DECISION MADE: 04-JAN-08 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI FLIER'S QUALITY WATER SYSTEMS INC 510(k) NO: K071104(TRADITIONAL)
ATTN: JAMES FLIER PHONE NO : 616-583-9040 7425 CLYDE PARK AVENUE SW SE DECISION MADE: 14-JAN-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA BYRON CENTER, MI 49315 DEVICE: MICROSHEATH XL CATHETERS FLOWCARDIA, INC. 510(k) NO: K073289(TRADITIONAL)
ATTN: DUSTIN MICHAELS PHONE NO : 408-617-0352 745 N. PASTORIA AVE. SE DECISION MADE: 11-JAN-08 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPULSE 6000D/7000DP FLUKE BIOMEDICAL 510(k) NO: K072114(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 28-JAN-08 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROWAVE TISSUE COAGULATION SYSTEM (MTCS) FOUNDRY NEWCO X, INC. 510(k) NO: K072870(TRADITIONAL)
ATTN: GREGORY MATHISON PHONE NO : 218-387-1559 199 JEFFERSON DRIVE SE DECISION MADE: 14-JAN-08 MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM GE HEALTHCARE SYSTEMS INFORMATION 510(k) NO: K073625(SPECIAL)
ATTN: MARGARET MUCHA PHONE NO : 414-721-4535 9900 INNOVATION DRIVE SE DECISION MADE: 25-JAN-08 WAUWATOSA, WI 53226 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VENTRI 1.1 GE MEDICAL SYSTEMS F.I. HAIFA 510(k) NO: K080124(TRADITIONAL)
ATTN: LAURENCE BIGIO PHONE NO : 972 4 8563633 4 HAYOZMA ST. SE DECISION MADE: 31-JAN-08 TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K073462(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685 86 PILGRIN RD. SE DECISION MADE: 11-JAN-08 NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER GE MEDICAL SYSTEMS, LLC 510(k) NO: K073167(TRADITIONAL)
ATTN: PHONE NO : 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 04-JAN-08 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS GENERAL ATOMICS 510(k) NO: K072523(TRADITIONAL)
ATTN: CHARLES YU PHONE NO : 858-455-4761 12889 GREGG COURT SE DECISION MADE: 22-JAN-08 POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PATRIOT SPACERS GLOBUS MEDICAL, INC. 510(k) NO: K072970(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 18-JAN-08 VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA AUDUBON, PA 19403 DEVICE: PATRIOT SPACERS: COLONIAL ACDF GLOBUS MEDICAL, INC. 510(k) NO: K072991(TRADITIONAL) ATTN: KELLY J BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 18-JAN-08 VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA AUDUBON, PA 19403 DEVICE: H-LINK INTEGRATED ROD GLOBUS MEDICAL, INC. 510(k) NO: K073517(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000 2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 03-JAN-08 VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA AUDUBON, PA 19403 DEVICE: HERO VASCULAR ACCESS DEVICE GRAFTCATH INC. 510(k) NO: K071778(TRADITIONAL)
ATTN: LAURIE LYNCH PHONE NO : 952-224-2225 6545 CITY WEST PARKWAY SE DECISION MADE: 30-JAN-08 EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON ST HAND BIOMECHANICS LAB, INC. 510(k) NO: K072432(TRADITIONAL)
ATTN: JEFF WOODHOUSE PHONE NO : 916-923-5073 77 SCRIPPS DR., SUITE 104 SE DECISION MADE: 09-JAN-08 SACRAMENTO, CA 95825 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANGER CRANIAL BAND HANGER PROSTHETICS & ORTHOTICS, IN510(k) NO: K072566(TRADITIONAL)
ATTN: IVAN J WASSERMAN PHONE NO : 202-585-6529 700 12TH STREET, NW SE DECISION MADE: 09-JAN-08 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HARDYDISK AST DORIPENEM 10 UG HARDY DIAGNOSTICS 510(k) NO: K080019(TRADITIONAL) ATTN: WENDY PHILLIPS PHONE NO : 805-346-2766 1430 WEST MCCOY LN. SE DECISION MADE: 29-JAN-08 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM HEEYOUNG CO., LTD. 510(k) NO: K073292(TRADITIONAL)
ATTN: CARL THOMAS PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 18-JAN-08 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT HITACHI MEDICAL CORP. 510(k) NO: K073310(ABBREVIATED)
ATTN: DOUG THISTLEWAITE PHONE NO : 330-425-1313 1959 SUMMIT COMMERCE PARK SE DECISION MADE: 18-JAN-08 TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SILK'N HOME SKINOVATIONS LTD. 510(k) NO: K072906(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 9 7678807 4 HACHAROSHET ST. SE DECISION MADE: 23-JAN-08 POB 7028 510(k) SUMMARY AVAILABLE FROM FDA KFAR SABA, ISRAEL 44640 DEVICE: SLIT LAMP HUVITZ CO., LTD. 510(k) NO: K073190(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 11-JAN-08 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: OXYVU -1 HYPERSPECTRAL TISSUE OXYGENATION (HTO) MEASUREMENT SYST HYPERMED, INC. 510(k) NO: K073656(SPECIAL)
ATTN: CHAS BURR PHONE NO : 781-789-1646 11 MYSTIC AVE. SE DECISION MADE: 25-JAN-08 WINCHESTER, MA 01890-2920 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY IDEV TECHNOLOGIES, INC. 510(k) NO: K071646(TRADITIONAL)
ATTN: TIMOTHY R PLACEK PHONE NO : 281-333-1998 1120 NASA PKWY., SUITE 600 SE DECISION MADE: 31-JAN-08 HOUSTON, TX 77058 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMIX INSIGHT X-RAY SYSTEMS IMIX ADR FINLAND OY 510(k) NO: K073114(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854 P.O. BOX 7007 SE DECISION MADE: 17-JAN-08 DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPLASA-HOECHST GMBH IMPLANTS IMPLASA-HOECHST GMBH 510(k) NO: K071240(TRADITIONAL) ATTN: BENNY ARAZY PHONE NO : 972 4 9940337 MIZPE AVIV SE DECISION MADE: 24-JAN-08 INDUSTRIAL PARK 13 510(k) STATEMENT M.P. MISGAV, ISRAEL 20187 DEVICE: CANDELA-INOLASE SERENITY PRO PSF SYSTEM INOLASE, LTD. 510(k) NO: K072925(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116 291 HILLSIDE AVE. SE DECISION MADE: 10-JAN-08 SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTA LITE F-ACTIN IGA ELISA INOVA DIAGNOSTICS, INC. 510(k) NO: K072967(TRADITIONAL) ATTN: BRYS C MYERS PHONE NO : 858-586-9900 9900 OLD GROVE RD. SE DECISION MADE: 28-JAN-08 SAN DIEGO, CA 92131-1638 510(k) STATEMENT DEVICE: PEEK SPINAL SPHERES INTERBODY INNOVATIONS, LLP 510(k) NO: K073105(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 03-JAN-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 INTERNATIONAL BIOPHYSICS CORP. 510(k) NO: K072688(ABBREVIATED)
ATTN: DAVID SHOCKLEY PHONE NO : 523-263-3244 2101-2 E. ST. ELMO SE DECISION MADE: 11-JAN-08 SUITE 275 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78744 DEVICE: LYOPHILIZED EARLY CLEAVAGE MEDIUM (ECM) KIT IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K072607(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706 2511 DAIMLER ST SE DECISION MADE: 25-JAN-08 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LYOPHILIZED MULTIBLAST MEDIUM KIT IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K072608(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706 2511 DAIMLER ST SE DECISION MADE: 30-JAN-08 SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: P-NAIN SYSTEM JEISYS MEDICAL, INC. 510(k) NO: K072833(TRADITIONAL) ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 24-JAN-08 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: NATURAL BRIDGE LP TRANSVERSE CONNECTORS K2M, INC. 510(k) NO: K072914(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 03-JAN-08 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 K2M, INC. 510(k) NO: K080024(SPECIAL) ATTN: RICHARD W WOODS PHONE NO : 703-777-3155 751 MILLER DR. SE, SUITE F1 SE DECISION MADE: 24-JAN-08 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KAWASUMI LABORATORIES LARGE WING SETS WITH ANTINEEDLE STICK PROT KAWASUMI LABORATORIES, INC. 510(k) NO: K073257(TRADITIONAL)
ATTN: JACK PAVLO PHONE NO : 813-630-5554 4723 OAK FAIR BLVD SE DECISION MADE: 25-JAN-08 TAMPA, FL 33610 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAXCEM 2 KERR CORPORATION 510(k) NO: K073209(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484 1717 WEST COLLINS AVE. SE DECISION MADE: 29-JAN-08 ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PEGASUS STEERABLE (PTCA) GUIDEWIRE LAKE REGION MFG., INC. 510(k) NO: K073655(SPECIAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111 340 LAKE HAZELTINE DR. SE DECISION MADE: 28-JAN-08 CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LANX INTERVERTEBRAL BODY FUSION DEVICE LANX, LLC 510(k) NO: K073144(TRADITIONAL)
ATTN: GREG CAUSEY PHONE NO : 303-443-7500 390 INTERLOCKEN CRESCENT SE DECISION MADE: 24-JAN-08 SUITE 890 510(k) SUMMARY AVAILABLE FROM FDA BROOMFIELD, CO 80021 DEVICE: KINETIC-SL ANTERIOR CERVICAL PLATE SYSTEM LIFE SPINE 510(k) NO: K073479(SPECIAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117 2401 W. HASSELL RD. SE DECISION MADE: 09-JAN-08 SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60169 DEVICE: LIFE SPINE CROSS CONNECTOR LIFE SPINE 510(k) NO: K073480(SPECIAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117 2401 W. HASSELL RD. SE DECISION MADE: 04-JAN-08 SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60169 DEVICE: ORTHO ANCHOR SCREWS M.I.S. IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K073461(TRADITIONAL)
ATTN: IMAN KHORSHID PHONE NO : 972 498 09966 P.O.B. 110 SE DECISION MADE: 25-JAN-08 SHLOMI INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA SHLOMI, ISRAEL 22832 DEVICE: MAKO SURGICAL TACTILE GUIDANCE SYSTEM (TGS) MAKO SURGICAL CORP. 510(k) NO: K072806(TRADITIONAL)
ATTN: WILLIAM TAPIA PHONE NO : 954-927-2044 2555 DAVIE RD. SE DECISION MADE: 24-JAN-08 FORT LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATI MAQUET CARDIOPULMONARY AG 510(k) NO: K070605(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 497 4789210 HECHINGER STRASSE 38 SE DECISION MADE: 04-JAN-08 HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COAT MAQUET CARDIOPULMONARY AG 510(k) NO: K071774(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 497 4789210 HECHINGER STRASSE 38 SE DECISION MADE: 23-JAN-08 HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ORTHO-WRAP BIORESORBABLE SHEET MAST BIOSURGERY 510(k) NO: K072190(TRADITIONAL)
ATTN: KENNETH K KLEINHENZ PHONE NO : 858-458-0900 6749 TOP GUN STREET, SUITE 108 SE DECISION MADE: 16-JAN-08 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMALL LUMEN PERITONEAL CATHETER MEDTRONIC NEUROSURGERY 510(k) NO: K073139(SPECIAL)
ATTN: JEFFREY HENDERSON PHONE NO : 805-968-1546 125 CREMONA DR. SE DECISION MADE: 30-JAN-08 GOLETA, CA 93117 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROGENIX DMB PUTTY MEDTRONIC SOFAMOR DANEK 510(k) NO: K072265(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 09-JAN-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MERITS E700 PORCE LIFT MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K073513(ABBREVIATED)
ATTN: STEVE CHAO PHONE NO : 886 423 594985 9, ROAD 36 SE DECISION MADE: 14-JAN-08 TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA TAICHUNG, CHINA (TAIWAN) 407 DEVICE: TENDER ORTHO BOND-ENA BOND-ENA ETCH MICERIUM S.P.A. 510(k) NO: K072978(TRADITIONAL)
ATTN: EUGENIO MICELI PHONE NO : 39 018 57885880 VIA MARCONI 83 SE DECISION MADE: 17-JAN-08 AVEGNO, GENOA, ITALY 16030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MO MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K073198(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 203-431-1511 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 11-JAN-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROMED BRAIN SPY PLUS, EMBIA TITANIUM DEVICES MICROMED S.P.A. 510(k) NO: K071782(ABBREVIATED)
ATTN: MONICA CAMILLO PHONE NO : 390 415 937000 VIA GIOTTO 2 SE DECISION MADE: 10-JAN-08 MOGLIANO VENETO (TV), ITALY 31021 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: MICROMRI WRIST COIL MICROMRI, INC. 510(k) NO: K073131(TRADITIONAL)
ATTN: HRISHIKESH GADAGKAR PHONE NO : 215-564-1002 1429 WALNUT ST., SUITE 1102 SE DECISION MADE: 18-JAN-08 PHILADELPHIA, PA 19102 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HYDROCOIL EMBOLIC SYSTEMS (HES) MICROVENTION, INC. 510(k) NO: K071939(TRADITIONAL)
ATTN: VINCENT CUTARELLI PHONE NO : 949-951-0505 75 COLUMBIA SE DECISION MADE: 11-JAN-08 ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MONDEAL ENDOSCOPIC TISSUE RECESSION AND RELEASE SYSTEM MONDEAL NORTH AMERICA, INC 510(k) NO: K072684(TRADITIONAL)
ATTN: JAY EVANS PHONE NO : 858-901-4123 PO BOX 500521 SE DECISION MADE: 04-JAN-08 SAN DIEGO, CA 92150 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL MORE DIAGNOSTICS 510(k) NO: K072257(TRADITIONAL) ATTN: JAMES W SNIPES PHONE NO : 805-528-6005 2020 11TH ST. SE DECISION MADE: 30-JAN-08 LOS OSOS, CA 93402 510(k) STATEMENT DEVICE: ALGO 5 NEWBORN HEARING SCREENER NATUS MEDICAL, INC. 510(k) NO: K073665(SPECIAL)
ATTN: TOM BOLES PHONE NO : 650-801-7262 1501 INDUSTRIAL RD. SE DECISION MADE: 25-JAN-08 SAN CARLOS, CA 94070 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEOMED FEEDING TUBE NEOMED, INC. 510(k) NO: K072881(TRADITIONAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678-428-6978 717 LAKEGLEN DR. SE DECISION MADE: 09-JAN-08 SUWANEE, GA 30024 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOLTOUCH MODELS NS 160 AND LC215 COOLIPO NEW STAR LASERS, INC. 510(k) NO: K072751(TRADITIONAL)
ATTN: NATALIE R VOLLRATH PHONE NO : 916-677-1900 9085 FOOTHILLS BLVD. SE DECISION MADE: 02-JAN-08 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EEG-1100A SWITCH BOX NIHON KOHDEN AMERICA, INC. 510(k) NO: K073491(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555 90 ICON ST. SE DECISION MADE: 11-JAN-08 FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLINICAL ELECTRONIC THERMOMETERS, MODEL(S) MT901, MT518, ECT-1 NINGBO HUAHUI MEDICAL INSTRUMENTS 510(k) NO: K072635(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 8D, NO. 19 LANE 999 SE DECISION MADE: 17-JAN-08 SHANGHAI, CHINA 200030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NOBELREPLACE HEXAGONAL IMPLANT NOBEL BIOCARE USA LLC 510(k) NO: K073142(SPECIAL)
ATTN: KAM LEUNG PHONE NO : 714-282-4800 22715 SAVI RANCH PARKWAY SE DECISION MADE: 11-JAN-08 YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPY FLUORESCENT IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K073088(TRADITIONAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822 2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 10-JAN-08 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPY FLUORESCENT IMAGING SYSTEM NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K073130(TRADITIONAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822 2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 10-JAN-08 MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NUVASIVE HELIX MINI ACP SYSTEM NUVASIVE, INC. 510(k) NO: K073275(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868 4545 TOWNE CENTRE COURT SE DECISION MADE: 29-JAN-08 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE OCEANIC MEDICAL PRODUCTS, INC. 510(k) NO: K072420(SPECIAL)
ATTN: HOWARD HOLSTEIN, ESQ PHONE NO : 202-637-5813 555 THIRTEENTH STREET, NW. SE DECISION MADE: 22-JAN-08 WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: JJG EVOLUTION ORTHODONTIC IMPLANT SYSTEM ODONTIT SA 510(k) NO: K072917(TRADITIONAL)
ATTN: MARIO GERSBERG PHONE NO : 011 490 29500 MARCELO T DE ALVEAR 2099 SE DECISION MADE: 14-JAN-08 3 DEG A-C1122AAE 510(k) SUMMARY AVAILABLE FROM FDA BUENOS AIRES, ARGENTINA DEVICE: MARK III WAVEGUIDE FIBER WITH LOW PROFILE TIP OMNIGUIDE, INC. 510(k) NO: K073313(SPECIAL)
ATTN: DOUGLAS W WOODRUFF PHONE NO : 617-551-8404 ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 02-JAN-08 3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA CAMBRIDGE, MA 02139 THIRD PARTY REVIEW DEVICE: KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK P OREX COMPUTED RADIOGRAPHY LTD 510(k) NO: K073670(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 490 99617 STAR YOKNEAM BLDG SE DECISION MADE: 25-JAN-08 P.O. BOX 505 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM, ISRAEL 20692 DEVICE: TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) OSCOR INC. 510(k) NO: K072770(TRADITIONAL) ATTN: MILA DOSKOCIL PHONE NO : 727-937-2511 3816 DE SOTO BLVD. SE DECISION MADE: 22-JAN-08 PALM HARBOR, FL 34683 510(k) STATEMENT DEVICE: MS SYSTEM (PROVISIONAL) OSSTEM IMPLANT CO.,LTD 510(k) NO: K072871(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909 5536 TROWBRIDGE DRIVE SE DECISION MADE: 10-JAN-08 DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: START JUNIOR OTTO BOCK HEALTH CARE, LP 510(k) NO: K073512(TRADITIONAL)
ATTN: BERT HERMAN PHONE NO : 763-553-9464 2 CARLSON PWY. STE. 100 SE DECISION MADE: 14-JAN-08 MINNEAPOLIS, MN 55447-4467 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DSS PARADIGM SPINE, LLC 510(k) NO: K072969(TRADITIONAL) ATTN: JUSTIN EGGLETON PHONE NO : 202-552-5800 1331 H STREET NW SE DECISION MADE: 24-JAN-08 12TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-100 PHADIA US INC. 510(k) NO: K072149(TRADITIONAL)
ATTN: MARTIN MANN PHONE NO : 269-492-1957 4169 COMMERCIAL AVE. SE DECISION MADE: 15-JAN-08 PORTAGE, MI 49002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PIONEER SLIMFUSE ANTERIOR CERVICAL PLATING SYSTEM PIONEER SURGICAL TECHNOLOGY 510(k) NO: K072703(TRADITIONAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 10-JAN-08 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUANTUM-MIS CANNULATED SYSTEM PIONEER SURGICAL TECHNOLOGY 510(k) NO: K080026(SPECIAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812 375 RIVER PARK CIRCLE SE DECISION MADE: 28-JAN-08 MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS PLAYTEX PRODUCTS, INC. 510(k) NO: K073662(SPECIAL)
ATTN: KEITH EDGETT PHONE NO : 302-678-6880 804 WALKER RD. SE DECISION MADE: 17-JAN-08 DOVER, DE 19904 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: POINTCARE NOW SYSTEM POINTCARE TECHNOLOGIES INC. 510(k) NO: K072869(TRADITIONAL)
ATTN: MAURICE N DOIRE PHONE NO : 508-281-6925 181 CEDAR HILL ST. SE DECISION MADE: 14-JAN-08 MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 POSSIS MEDICAL, INC. 510(k) NO: K073441(TRADITIONAL)
ATTN: MIKE BURNSIDE PHONE NO : 763-780-4555 9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 24-JAN-08 MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPERMCHECK VASECTOMY PRINCETON BIOMEDITECH CORP. 510(k) NO: K073039(TRADITIONAL)
ATTN: KYUNG-AH KIM PHONE NO : 732-274-1000 4242 U.S. RT. 1 SE DECISION MADE: 24-JAN-08 MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFLU+ ASSAY PRODESSE, INC. 510(k) NO: K073029(TRADITIONAL)
ATTN: KAREN HARRINGTON PHONE NO : 262-446-0700 W229 N 1870 WESTWOOD DR. SE DECISION MADE: 04-JAN-08 WAUKESHA, WI 53186 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: BPCARD, MODEL Z-7000-0700 QRS DIAGNOSTIC, LLC. 510(k) NO: K073630(SPECIAL)
ATTN: MARY KAY JENSEN PHONE NO : 763-559-8492 14755 27TH AVE.NORTH SE DECISION MADE: 11-JAN-08 PLYMOUTH, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RADIANCY MISTRAL DEVICE RADIANCY (ISRAEL) LTD. 510(k) NO: K072331(TRADITIONAL)
ATTN: ZVI LADIN PHONE NO : 781-407-0900 990 WASHINGTON ST. SE DECISION MADE: 07-JAN-08 DEDHAM, MA 02026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REDLINE ALCOHOL BREATH TESTER REDLINE PRODUCTS (PTY) LTD. 510(k) NO: K072953(TRADITIONAL) ATTN: HUGH A BUTLER PHONE NO : 27 21 8537728 10 CROMPTON ROAD SE DECISION MADE: 07-JAN-08 STRAND INDUSTRIA, WESTERN CAPE, SO510(k) STATEMENT DEVICE: BIOSET XCH REGENERATION TECHNOLOGIES, INC. 510(k) NO: K072238(TRADITIONAL)
ATTN: TRAVIS AROLA PHONE NO : 386-418-8888 11621 RESEARCH CIR. SE DECISION MADE: 25-JAN-08 P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA ALACHUA, FL 32616-2650 DEVICE: TXCONTROL RESMED LTD. 510(k) NO: K072615(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 04-JAN-08 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REUSABLE, DISPOSABLE LAPAROSCOPIC INSTRUMENT AND SURGICAL DEVICE RG MEDICAL USA 510(k) NO: K072753(TRADITIONAL) ATTN: WINFRIED REICH PHONE NO : 615-269-7256 468 CRAIGHEAD ST. SE DECISION MADE: 25-JAN-08 NASHVILLE, TN 37204 510(k) STATEMENT DEVICE: RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K072736(TRADITIONAL)
ATTN: JAMES MEWBORNE PHONE NO : 803-252-1222 1256 FIRST ST. SOUTH EXTENSION SE DECISION MADE: 22-JAN-08 COLUMBIA, SC 29209 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RICHTER MALE LATEX CONDOM RICHTER RUBBER TECHNOLOGY SBN BHD 510(k) NO: K070511(ABBREVIATED) ATTN: SUBRAMANIAM NARAYANASAMY PHONE NO : 604 416 1668/9 PO BOX 12139 SE DECISION MADE: 14-JAN-08 DURHAM, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANDHELD BASE UNIT ROCHE DIAGNOSTICS CORP. 510(k) NO: K072920(ABBREVIATED) ATTN: JASON FISHER PHONE NO : 317-521-3501 9115 HAGUE RD. SE DECISION MADE: 31-JAN-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEEDLE-TRAP/NEEDLE SAFETY LABEL SCHREINER MEDIPHARM 510(k) NO: K073206(TRADITIONAL)
ATTN: LEE LEICHTER PHONE NO : 239-768-1118 7609 CAMERON CIRCLE SE DECISION MADE: 16-JAN-08 FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SCIMAGE PICOMENTERPRISE SCIMAGE, INC. 510(k) NO: K073169(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-276-2648 16303 PANORAMIC WAY SE DECISION MADE: 09-JAN-08 SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PC-180 / PRINCE 180 EASY ECG MONITOR SHENZHEN CREATIVE INDUSTRY CO., LT510(k) NO: K073152(TRADITIONAL)
ATTN: PHONE NO : 2/F, BLOCK 3 NANYOU TIAN' SE DECISION MADE: 10-JAN-08 AN INDUSTRY TOWN 510(k) SUMMARY AVAILABLE FROM FDA SHENZHEN,GD, CHINA 518054 THIRD PARTY REVIEW DEVICE: PM-60 PULSE OXIMETER SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K072581(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 08-JAN-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-22 SHIMADZU MEDICAL SYSTEMS 510(k) NO: K071287(TRADITIONAL)
ATTN: DON KARLE PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 09-JAN-08 TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-12 SHIMADZU MEDICAL SYSTEMS 510(k) NO: K071289(TRADITIONAL)
ATTN: DON KARLE PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 09-JAN-08 TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-11 SHIMADZU MEDICAL SYSTEMS 510(k) NO: K071291(TRADITIONAL)
ATTN: DON KARLE PHONE NO : 310-217-8855 20101 SOUTH VERMONT AVE. SE DECISION MADE: 09-JAN-08 TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: N95 SURGICAL RESPIRATOR, TYPE AP0018 AND AP0028 SHUENN BAO SHING CORPORATION 510(k) NO: K072067(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO. 58, FU CHIUN STREET SE DECISION MADE: 08-JAN-08 HSIN CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM SICEL TECHNOLOGIES, INC. 510(k) NO: K080004(SPECIAL)
ATTN: TAMMY B CARREA PHONE NO : 919-465-2236 3800 GATEWAY CENTRE BLVD. SE DECISION MADE: 23-JAN-08 SUITE 308 510(k) SUMMARY AVAILABLE FROM FDA MORRISVILLE, NC 27560 DEVICE: SYNGO VOLUME PERFUSION-CT NEURO SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K073238(TRADITIONAL)
ATTN: RALF HOFMANN PHONE NO : 499 191 188170 HENKESTRASSE 127 SE DECISION MADE: 03-JAN-08 ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW
DEVICE: LITHOSKOP SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K070665(TRADITIONAL)
ATTN: KIM RENDON PHONE NO : 610-448-1773 51 VALLEY STREAM PKWY. SE DECISION MADE: 04-JAN-08 MS E-50 510(k) SUMMARY AVAILABLE FROM FDA MALVERN, PA 19355 DEVICE: SMITH & NEPHEW MIS HIP STEM SMITH & NEPHEW, INC. 510(k) NO: K072417(ABBREVIATED)
ATTN: RISHI SINHA PHONE NO : 901-399-6054 1450 BROOKS RD. SE DECISION MADE: 10-JAN-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SOMNOMED MAS FLEX "S" SOMNOMED INC. 510(k) NO: K073004(TRADITIONAL)
ATTN: ASHLEY TRUITT PHONE NO : 940-395-4555 3537 TEASLEY LANE SE DECISION MADE: 30-JAN-08 DENTON, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFESTEP MAX POWER-INJECTABLE INFUSION SET SPECIALIZED HEALTH PRODUCTS INTERN510(k) NO: K073050(TRADITIONAL)
ATTN: MARK NELSON PHONE NO : 801-298-3360 585 WEST 500 SOUTH SE DECISION MADE: 25-JAN-08 BOUNTIFUL, UT 84010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYSTAL SPINAL ELEMENTS, INC. 510(k) NO: K073351(TRADITIONAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816 2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 24-JAN-08 CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CHAMELEON FIXATION SYSTEM SPINEFRONTIER, INC. 510(k) NO: K071420(TRADITIONAL)
ATTN: THOMAS CARLSON PHONE NO : 978-232-3990 100 CUMMINGS CENTER SE DECISION MADE: 16-JAN-08 SUITE 240C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, SPIRE BIOMEDICAL INC 510(k) NO: K073092(TRADITIONAL)
ATTN: RAYMOND KELLY PHONE NO : 781-325-0771 ONE PATRIOTS PARK SE DECISION MADE: 29-JAN-08 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED T SPIRE BIOMEDICAL INC 510(k) NO: K073093(TRADITIONAL)
ATTN: RAYMOND KELLY PHONE NO : 781-325-0771 ONE PATRIOTS PARK SE DECISION MADE: 22-JAN-08 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO PROXIS SYSTEM ST. JUDE MEDICAL 510(k) NO: K073563(SPECIAL)
ATTN: LINH PHAM PHONE NO : 763-383-0900 6550 WEDGWOOD RD. NORTH SE DECISION MADE: 31-JAN-08 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA MAPLE GROVE, MN 55311 DEVICE: VERIFY CHALLENGE PACKS - VERSION 2 STERIS CORPORATION 510(k) NO: K073683(SPECIAL)
ATTN: JOHN SCOVILLE PHONE NO : 440-392-7330 5960 HEISLEY RD. SE DECISION MADE: 25-JAN-08 MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CERVICAL MD, MODEL C10 STI MEDICAL SYSTEMS 510(k) NO: K072691(TRADITIONAL)
ATTN: ROLF WOLTERS PHONE NO : 808-540-4728 733 BISHOP STREET SE DECISION MADE: 31-JAN-08 SUITE 3100 510(k) SUMMARY AVAILABLE FROM FDA HONOLULU, HI 96813 DEVICE: SYNOCTA ABUTMENTS STRAUMANN USA 510(k) NO: K073628(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168 60 MINUTEMAN ROAD SE DECISION MADE: 22-JAN-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRIATHLON SCREW-FIXATION TIBIAL BASEPLATE STRYKER ORTHOPAEDICS 510(k) NO: K072575(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612 325 CORPORATE DRIVE SE DECISION MADE: 07-JAN-08 MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIBEL SA VASCULAR CLAMP SURGICAL INSTRUMENTS BELGIUM SA 510(k) NO: K072834(TRADITIONAL)
ATTN: WILLIAM F GREENROSE PHONE NO : 001-603-3693 220 RIVER RD. SE DECISION MADE: 09-JAN-08 CLAREMONT, NH 03743-5647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: STALIF (TM) C SURGICRAFT LTD. 510(k) NO: K072415(ABBREVIATED)
ATTN: DONALD W GUTHNER PHONE NO : 646-460-2984 111 HILL ROAD SE DECISION MADE: 25-JAN-08 DOUGLASSVILLE, PA 19518 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM SUROS SURGICAL SYSTEMS, INC, A HOL510(k) NO: K072913(SPECIAL)
ATTN: PAULA A GRAY PHONE NO : 317-344-7500 6100 TECHNOLOGY CENTER DR. SE DECISION MADE: 04-JAN-08 INDIANAPOLIS, IN 46278 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS SYNTHES (USA) 510(k) NO: K073135(TRADITIONAL)
ATTN: JILL SHERMAN PHONE NO : 610-719-6538 1302 WRIGHTS LANE EAST SE DECISION MADE: 29-JAN-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES OC FUSION AND SYNAPSE SYSTEMS SYNTHES SPINE CO.LP 510(k) NO: K072434(TRADITIONAL)
ATTN: SUSAN LEWANDOWSKI PHONE NO : 610-719-5712 1302 WRIGHTS LANE EAST SE DECISION MADE: 10-JAN-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITALLINK3 MOBILE VITAL SIGNS SYSTEM TELEMEDIC SYSTEMS LTD 510(k) NO: K073094(SPECIAL)
ATTN: GERALD L BUSS PHONE NO : 440 870 1417330 10 BILLETFIELD SE DECISION MADE: 04-JAN-08 TAUNTON, SOMERSET, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CYSTATIN C KIT FOR USE ON THE SPAPLUS ANALYZER THE BINDING SITE 510(k) NO: K072166(TRADITIONAL) ATTN: JAY GELLER PHONE NO : 310-449-1399 2425 WEST OLYMPIC BOULEVARD SE DECISION MADE: 24-JAN-08 WEST TOWER SUITE 4000 510(k) STATEMENT SANTA MONICA, CA 90404 DEVICE: MODIFICATION TO THERMAGE THERMACOOL SYSTEM THERMAGE, INC. 510(k) NO: K072849(TRADITIONAL)
ATTN: PAMELA M BUCKMAN PHONE NO : 510-259-7116 25881 INDUSTRIAL BLVD. SE DECISION MADE: 18-JAN-08 HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Y-GLIDE THOMAS MEDICAL PRODUCTS, INC. 510(k) NO: K072745(SPECIAL)
ATTN: TIM STOUDT PHONE NO : 610-296-3000 65 GREAT VALLEY PKWY. SE DECISION MADE: 04-JAN-08 MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PRO TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K073431(SPECIAL) ATTN: ARMANDO TORRESCANO PHONE NO : 760-602-2929 3108 AVENIDA OLMEDA SE DECISION MADE: 14-JAN-08 CARLSBAD, CA 92009 510(k) STATEMENT DEVICE: TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT TISSUELINK MEDICAL, INC. 510(k) NO: K073495(SPECIAL)
ATTN: SOM KOVVURI PHONE NO : 603-742-1515 ONE WASHINGTON CENTER SE DECISION MADE: 09-JAN-08 SUITE #400 510(k) SUMMARY AVAILABLE FROM FDA DOVER, NH 03820 DEVICE: VANTAGE TITAN, MODEL MRT-1504/S3 TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K080038(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000 2441 MICHELLE DR. SE DECISION MADE: 22-JAN-08 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TRANS1 AXIAL FIXATON SYSTEM TRANS1 INCORPORATED 510(k) NO: K073514(SPECIAL)
ATTN: WILLIAM JACKSON PHONE NO : 910-332-1727 411 LANDMARK DR. SE DECISION MADE: 11-JAN-08 WILMINGTON, NC 28412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K073424(TRADITIONAL) ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909 982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 22-JAN-08 CLEVELAND, OH 44131 510(k) STATEMENT DEVICE: PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 TYRX PHARMA, INC. 510(k) NO: K063091(TRADITIONAL)
ATTN: MASON W DIAMOND PHONE NO : 732-246-8676 1 DEER PARK DR. SE DECISION MADE: 16-JAN-08 SUITE G 510(k) SUMMARY AVAILABLE FROM FDA MONMOUTH JUNCTION, NJ 08852 DEVICE: PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER UNITED MEDICAL SYSTEMS, INC. 510(k) NO: K072538(TRADITIONAL)
ATTN: JEFFREY K SHAPIRO PHONE NO : 202-737-5600 700 THIRTEENTH STREET NW SE DECISION MADE: 30-JAN-08 WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VARI-LASE WIRE FIBER VASCULAR SOLUTIONS, INC. 510(k) NO: K072332(TRADITIONAL)
ATTN: DEBORAH NEYMARK PHONE NO : 763-656-4300 6464 SYCAMORE COURT NORTH SE DECISION MADE: 10-JAN-08 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO AVEA VENTILATOR VIASYS RESPIRATORY CARE INC 510(k) NO: K073069(TRADITIONAL)
ATTN: TOM GUTIERREZ PHONE NO : 760-778-7255 1100 BIRD CENTER DR. SE DECISION MADE: 25-JAN-08 PALM SPRINGS, CA 92262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VOLCANO S5/S5I INTRAVASCULAR IMAGING AND PRESSURE SYSTEM VOLCANO CORPORATION 510(k) NO: K071554(SPECIAL)
ATTN: LORRY W HUFFMAN PHONE NO : 916-231-4503 2870 KILGORE RD. SE DECISION MADE: 04-JAN-08 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IV VOLCANO CORPORATION 510(k) NO: K073473(SPECIAL)
ATTN: ARLENE BLADES PHONE NO : 916-231-4558 2870 KILGORE RD. SE DECISION MADE: 14-JAN-08 RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K072367(TRADITIONAL)
ATTN: EHAB M ESMAIL PHONE NO : 901-867-9971 5677 AIRLINE RD. SE DECISION MADE: 09-JAN-08 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOFOAM BONE WEDGE WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K073535(SPECIAL)
ATTN: BRAD SHEALS PHONE NO : 901-867-4597 5677 AIRLINE RD. SE DECISION MADE: 07-JAN-08 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BUTREX BUTTRESS PLATING SYSTEM X-SPINE SYSTEMS, INC. 510(k) NO: K072943(TRADITIONAL)
ATTN: DAVID KIRSCHMAN PHONE NO : 937-847-8400 452 ALEXANDERSVILLE RD. SE DECISION MADE: 28-JAN-08 MIAMISBURG, OH 45342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XORANCONNECT XORAN TECHNOLOGIES, INC. 510(k) NO: K073306(TRADITIONAL)
ATTN: AMY S KIM PHONE NO : 734-418-5151 309 N. FIRST STREET SE DECISION MADE: 07-JAN-08 ANN ARBOR, MI 48103-3301 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: A&J POCA01 OXYGEN CONCENTRATOR ZHONGSHAN A&J MEDICAL EQUIPMENT CO510(k) NO: K071608(TRADITIONAL)
ATTN: POLO CHEN PHONE NO : 86 760 3133726 3 SHENGHUI SOUTH ROAD SE DECISION MADE: 11-JAN-08 NANTOU TOWN, ZHONGSHAN CITY 510(k) SUMMARY AVAILABLE FROM FDA GUANGDONG, CHINA THIRD PARTY REVIEW DEVICE: TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED ZIMMER, INC. 510(k) NO: K072121(TRADITIONAL)
ATTN: PATRICIA JENKS PHONE NO : 574-371-8354 P.O. BOX 708 SE DECISION MADE: 07-JAN-08 WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 237 TOTAL WITH SUMMARIES 217 TOTAL WITH STATEMENTS 20
Updated February 5, 2008
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