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Medical Devices
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January 2008 510(k) Clearances
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
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