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Medical Devices
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October 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-OCT-2008 THROUGH 31-OCT-2008
DEVICE: PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
MEDTRONIC INC. 510(k) NO: K082464(TRADITIONAL)
ATTN: JEANMARIE SALES PHONE NO : 763-505-0256
710 MEDTRONIC PARKWAY NE SE DECISION MADE: 27-OCT-08
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALCOHOL PAD
122 CORPORATION 510(k) NO: K080466(TRADITIONAL)
ATTN: DONALD CANAL PHONE NO : 469-274-5030
3525 DEL MAR HEIGHTS SE DECISION MADE: 21-OCT-08
SUITE 430 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 1
659543 BC LTD. 510(k) NO: K073645(TRADITIONAL)
ATTN: HAROLD BERGMAN PHONE NO : 604 736 9890
#404, 1023 WOLFE AVE SE DECISION MADE: 21-OCT-08
VANCOUVER, BC, CANADA V6H 1V6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5
AALTO SCIENTIFIC LTD. 510(k) NO: K082717(TRADITIONAL)
ATTN: BRANDON J PEREZ PHONE NO : 760-431-7922
1959 KELLOGG AVE. SE DECISION MADE: 30-OCT-08
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECT
ABBOTT SPINE, INC. 510(k) NO: K082032(TRADITIONAL)
ATTN: DAVID PADGETT PHONE NO : 512-918-2700
5301 RIATA PARK CT., BLDG. F SE DECISION MADE: 06-OCT-08
AUSTIN, TX 78727 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCIN TOTAL KNEE SYSTEM
ACCELERATED INNOVATION, LLC 510(k) NO: K081127(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 973-777-8832
1033 US HIGHWAY 46 EAST SE DECISION MADE: 17-OCT-08
SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA
CLIFTON, NJ 07013
DEVICE: ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT
ADPHARMA, INC. 510(k) NO: K082071(TRADITIONAL)
ATTN: VIVEK RAMANA PHONE NO : 847-806-6789
415 WEST GOLF ROAD SE DECISION MADE: 02-OCT-08
SUITE 57 510(k) SUMMARY AVAILABLE FROM FDA
ARLINGTON HEIGHTS, IL 60005
DEVICE: ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K081545(TRADITIONAL)
ATTN: KIM REGIS PHONE NO : 714-247-8200
1700 EAST ST. ANDREW PL. SE DECISION MADE: 02-OCT-08
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITRECTOMY CUTTER AND ACCESSORIES
ADVANCED MEDICAL OPTICS, INC. 510(k) NO: K081681(ABBREVIATED)
ATTN: EVELYN DE LA VEGA PHONE NO : 714-247-8487
1700 E. ST. ANDREW PLACE SE DECISION MADE: 08-OCT-08
P.O. BOX 25162 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ANA, CA 92705-4933
DEVICE: AERONEB GO NEBULIZER
AEROGEN (IRELAND) LTD 510(k) NO: K081650(SPECIAL)
ATTN: FRANK ENRIGHT PHONE NO : 353 91 502550
GALWAY BUSINESS PARK SE DECISION MADE: 23-OCT-08
DANGAN, GALWAY, IRELAND 510(k) STATEMENT
DEVICE: EVIS MD PLANTIUM BLUE
AGELESS BEAUTY CORPORATION 510(k) NO: K082232(TRADITIONAL)
ATTN: JILL CREASY PHONE NO : 847-429-9631
675 PINE STREET SE DECISION MADE: 15-OCT-08
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVIS MD PLATINUM RED LIGHT THERAPY
AGELESS BEAUTY CORPORATION 510(k) NO: K082247(TRADITIONAL)
ATTN: JILL CREASY PHONE NO : 847-429-9631
675 PINE STREET SE DECISION MADE: 08-OCT-08
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXISCAN II DATA MANAGEMENT SYSTEM
AIRSEP CORP. 510(k) NO: K080348(TRADITIONAL)
ATTN: PETER WEISERBORN PHONE NO : 716-691-0202
401 CREEKSIDE DR. SE DECISION MADE: 09-OCT-08
BUFFALO, NY 14228-2085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
AKTINA MEDICAL PHYSICS CORP. 510(k) NO: K081935(TRADITIONAL)
ATTN: TONY SPACCAROTELLA PHONE NO : 845-268-0101
360 NORTH ROUTE 9W SE DECISION MADE: 07-OCT-08
CONGERS, NY 10920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE
AMERICAN MEDICAL SYSTEMS 510(k) NO: K081710(TRADITIONAL)
ATTN: DENISE THOMPSON PHONE NO : 952-933-6139
10700 BREN RD., WEST SE DECISION MADE: 15-OCT-08
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K082006(TRADITIONAL)
ATTN: STEPHANIE GEORGE PHONE NO : 952-930-6389
10700 BREN RD., WEST SE DECISION MADE: 20-OCT-08
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSELF CLOSED CATHETERIZATION SYSTEM
AMSINO INTERNATIONAL, INC. 510(k) NO: K082831(SPECIAL)
ATTN: CHING CHING SEAH PHONE NO : 909-626-5888
855 TOWNE CENTER DR. SE DECISION MADE: 23-OCT-08
POMONA, CA 91767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY
ANTICANCER INC 510(k) NO: K080851(TRADITIONAL)
ATTN: YUYING TAN PHONE NO : 858-654-2555
7917 OSTROW ST. SE DECISION MADE: 10-OCT-08
SAN DIEGO, CA 92111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCANSCOPE XT SYSTEM
APERIO TECHNOLOGIES 510(k) NO: K080254(TRADITIONAL)
ATTN: JEFF RYBERG PHONE NO : 760-539-1114
1430 VANTAGE COURT SE DECISION MADE: 31-OCT-08
VISTA, CA 92081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSUL
APPLIED NUTRITIONALS 510(k) NO: K081724(TRADITIONAL)
ATTN: ANITA PETITO PHONE NO : 610-865-9876
1890 BUCKNELL DR. SE DECISION MADE: 30-OCT-08
BETHLEHEM, PA 18015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISTAL RADIO-ULNAR JOINT IMPLANT
APTIS MEDICAL, LLC. 510(k) NO: K082839(SPECIAL)
ATTN: BRYAN BABB PHONE NO : 502-523-6738
3602 GLENVIEW AVE. SE DECISION MADE: 24-OCT-08
GLENVIEW, KY 40025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARAGON ONESHOT SYSTEM
ARAGON SURGICAL INC. 510(k) NO: K081312(TRADITIONAL)
ATTN: ALAN CURTIS PHONE NO : 650-543-3107
1810 EMBARCADERO ROAD, SUITE B SE DECISION MADE: 31-OCT-08
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
ARIZANT HEALTHCARE INC. 510(k) NO: K082217(TRADITIONAL)
ATTN: DAVID WESTLIN PHONE NO : 952-947-1277
10393 WEST 70TH ST. SE DECISION MADE: 06-OCT-08
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110
ARKRAY FACTORY USA, INC. 510(k) NO: K082417(SPECIAL)
ATTN: TOM SPEIKERS PHONE NO : 952-646-3168
5182 WEST 76TH ST. SE DECISION MADE: 21-OCT-08
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
ARTHROCARE CORP. 510(k) NO: K081893(TRADITIONAL)
ATTN: LAURA KASPEROWICZ PHONE NO : 949-585-2406
15285 ALTON PARKWAY, #200 SE DECISION MADE: 01-OCT-08
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE,
ARTHROCARE CORP. 510(k) NO: K082666(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 15-OCT-08
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25
ASAHI KASEI MEDICAL CO., LTD. 510(k) NO: K082515(SPECIAL)
ATTN: DAVID L WEST PHONE NO : 301-272-3113
1801 ROCKVILLE PIKE, SUITE 300 SE DECISION MADE: 03-OCT-08
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Y-ADAPTER
ASTHMATX, INC. 510(k) NO: K082174(TRADITIONAL)
ATTN: CARTER NAVARRO PHONE NO : 408-419-0100
888 ROSS DRIVE SE DECISION MADE: 20-OCT-08
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA
ASTRA TECH, INC. 510(k) NO: K081666(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERR. SE DECISION MADE: 07-OCT-08
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS SPINE SPACER
ATLAS SPINE INC. 510(k) NO: K081880(TRADITIONAL)
ATTN: JEANNETTE G DAILEY PHONE NO : 561-354-4319
1555 JUPITER PARK DR., STE. 4 SE DECISION MADE: 02-OCT-08
JUPITER, FL 33458 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20F
AVALON LABORATORIES, LLC 510(k) NO: K081820(TRADITIONAL)
ATTN: DAVID C FURR PHONE NO : 260-402-1598
5200 CRYSTAL WATER DR. SE DECISION MADE: 06-OCT-08
AUSTIN, TX 78735 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24F
AVALON LABORATORIES, LLC 510(k) NO: K081933(TRADITIONAL)
ATTN: LEE WIRTH PHONE NO : 310-761-8660
2610 E. HOMESTEAD PLACE SE DECISION MADE: 03-OCT-08
RANCHO DOMINGUEZ, CA 90220 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPIRALFUSE PERIPHERAL INFUSION SYSTEM
BACCHUS VASCULAR, INC. 510(k) NO: K082199(TRADITIONAL)
ATTN: BOB MCRAE PHONE NO : 408-980-8300
3110 CORONADO DR. SE DECISION MADE: 17-OCT-08
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B
BARRX MEDICAL, INCORPORATED 510(k) NO: K082202(SPECIAL)
ATTN: VIORICA FILIMON PHONE NO : 408-328-7302
540 OAKMEAD PARKWAY SE DECISION MADE: 08-OCT-08
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
BAUSCH & LOMB, INC. 510(k) NO: K082944(TRADITIONAL)
ATTN: DAVID THOMAS PHONE NO : 585-338-8467
1400 NORTH GOODMAN ST. SE DECISION MADE: 16-OCT-08
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRICOS A RESORBABLE BONE SUBSTITUTE
BAXTER HEALTHCARE CORP. 510(k) NO: K081717(TRADITIONAL)
ATTN: VALERIE FOLLOWELL PHONE NO : 847-270-4375
1620 WAULKEGAN RD. SE DECISION MADE: 10-OCT-08
MPGR-AL 510(k) SUMMARY AVAILABLE FROM FDA
MCGAW PARK, IL 60085-6730
DEVICE: GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
BAYER HEALTHCARE, LLC 510(k) NO: K082486(SPECIAL)
ATTN: ROGER SONNENBURG PHONE NO : 574-256-3441
430 SOUTH BEIGER ST. SE DECISION MADE: 08-OCT-08
MISHAWAKA, IN 46544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLUCONAZOLE 25UG BBL SENSI-DISC
BECTON DICKINSON & CO. 510(k) NO: K082271(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 06-OCT-08
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORICONAZOLE 1UG BBL SENSI-DISC
BECTON DICKINSON & CO. 510(k) NO: K082272(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 02-OCT-08
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHROMOPHARE E 778 AND E 558
BERCHTOLD HOLDING GMBH 510(k) NO: K083066(TRADITIONAL)
ATTN: SILKE GORAL PHONE NO : 49 746 1181155
LUDWIGSTALER STRABE 25 SE DECISION MADE: 30-OCT-08
TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT
BICON, LLC 510(k) NO: K073368(TRADITIONAL)
ATTN: VINCENT J MORGAN PHONE NO : 617-393-7215
501 ARBORWAY SE DECISION MADE: 10-OCT-08
BOSTON, MA 02130 510(k) STATEMENT
DEVICE: BINAXNOW G6PD TEST
BINAX, INC. 510(k) NO: K080003(TRADITIONAL)
ATTN: ANNE JEPSON PHONE NO : 207-730-5700
10 SOUTHGATE RD. SE DECISION MADE: 23-OCT-08
SCARBOROUGH, ME 04074 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM
BIO-TECHNOLOGY USA, INC. 510(k) NO: K073307(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 512-327-9997
1705 S. CAPITOL OF TEXAS HWY. SE DECISION MADE: 29-OCT-08
AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980
BIOLITEC, INC. 510(k) NO: K082263(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 24-OCT-08
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPERQ SYSTEM
BIOLOGICAL SIGNAL PROCESSING, LTD.510(k) NO: K082564(SPECIAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 20-OCT-08
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS CEA (S) ASSAY
BIOMERIEUX, INC. 510(k) NO: K080194(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314-731-7474
595 ANGLUM RD. SE DECISION MADE: 09-OCT-08
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMEN
BIOMET MANUFACTURING CORP. 510(k) NO: K080979(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 31-OCT-08
56. E. BELL DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: VANGUARD CR STEM HOUSINGS
BIOMET MANUFACTURING CORP. 510(k) NO: K082826(SPECIAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 24-OCT-08
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGY SPINAL SYSTEM (6.35 POLARIS)
BIOMET SPINE 510(k) NO: K081952(TRADITIONAL)
ATTN: VIVIAN KELLY PHONE NO : 973-299-9300
100 INTERPACE PARKWAY SE DECISION MADE: 07-OCT-08
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
BIOMET, INC. 510(k) NO: K082446(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 15-OCT-08
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTRO
BIONOSTICS, INC. 510(k) NO: K081478(TRADITIONAL)
ATTN: KATHLEEN STORRO PHONE NO : 978-772-7070
7 JACKSON RD. SE DECISION MADE: 06-OCT-08
DEVENS, MA 01434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH B
BIOPLATE, INC. 510(k) NO: K082757(SPECIAL)
ATTN: JESUS T FARINAS PHONE NO : 310-815-2100
3643 LENAWEE AVE. SE DECISION MADE: 01-OCT-08
LOS ANGELES, CA 90016-4310 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE PEDICLE SCREW SYSTEM
BLACKSTONE MEDICAL, INC. 510(k) NO: K082797(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838
1211 HAMBURG TURNPIKE SE DECISION MADE: 17-OCT-08
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WAYNE, NJ 07470
DEVICE: INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES
BMDI PTY LT. 510(k) NO: K081436(TRADITIONAL)
ATTN: JAMES BARLEY PHONE NO : 949-473-3058
33572 SEA WIND CT. SE DECISION MADE: 22-OCT-08
DANA POINT, CA 92629 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNITY BETA ANCHOR SYSTEM
BONUTTI RESEARCH, INC. 510(k) NO: K082906(SPECIAL)
ATTN: PATRICK G BALSMANN PHONE NO : 217-343-3412
P.O. BOX 1367 SE DECISION MADE: 30-OCT-08
EFFINGHAM, IL 62401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M
BOSTON SCIENTIFIC CORP. 510(k) NO: K081733(TRADITIONAL)
ATTN: WING NG PHONE NO : 508-683-4141
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 27-OCT-08
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAIGHT FIRE HOLMIUM LASER FIBER
BOSTON SCIENTIFIC CORP. 510(k) NO: K082928(TRADITIONAL)
ATTN: LAUREN B ANDERSON PHONE NO : 508-683-4707
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 16-OCT-08
MARLBOROUGH, MA 01756 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BOVIE ICON GENERAL PURPOSE RF GENERATOR
BOVIE MEDICAL 510(k) NO: K082109(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-803-8513
7100 30TH AVE. NORTH SE DECISION MADE: 02-OCT-08
ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL
BRIDGEPOINT MEDICAL 510(k) NO: K081187(TRADITIONAL)
ATTN: MICHAEL A DANIEL PHONE NO : 415-407-0223
8 SNOWBERRY COURT SE DECISION MADE: 08-OCT-08
ORINDA, CA 94563 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
C.R. BARD, INC. 510(k) NO: K080944(SPECIAL)
ATTN: TERRI MORRIS PHONE NO : 678-342-4922
13183 HARLAND DRIVE SE DECISION MADE: 23-OCT-08
COVINGTON, GA 30014-2655 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVE
C.R. BARD, INC. 510(k) NO: K082305(SPECIAL)
ATTN: GENEVIEVE BALUTOWSKI PHONE NO : 480-303-2524
1625 WEST 3RD ST. SE DECISION MADE: 31-OCT-08
P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85280-1740
DEVICE: VACORA VACUUM ASSISTED BIOPSY SYSTEM
C.R. BARD, INC. 510(k) NO: K082681(SPECIAL)
ATTN: CINDY MOSS PHONE NO : 480-379-2836
1625 WEST 3RD ST. SE DECISION MADE: 15-OCT-08
P.O. BOX 1740 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85281-1740
DEVICE: COLLAMEND FM IMPLANT
C.R. BARD, INC. 510(k) NO: K082687(TRADITIONAL)
ATTN: KEVIN G STEVENS PHONE NO : 401-825-8583
100 CROSSINGS BOULEVARD SE DECISION MADE: 17-OCT-08
WARWICK, RI 02886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
CALVARY SPINE LLC 510(k) NO: K082260(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 17-OCT-08
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
CARDINAL HEALTH 207, INC. 510(k) NO: K081670(TRADITIONAL)
ATTN: ANDRE VON MULLER PHONE NO : 714-283-8472
22745 SAVI RANCH PARKWAY SE DECISION MADE: 09-OCT-08
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLID
CARDIOVASCULAR SYSTEMS, INC. 510(k) NO: K082981(SPECIAL)
ATTN: DAVID D BROOKE PHONE NO : 651-259-2061
651 CAMPUS DR. SE DECISION MADE: 31-OCT-08
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CDB CLIP
CDB CORPORATION 510(k) NO: K080906(TRADITIONAL)
ATTN: JENS RUMSFELD PHONE NO : 910-383-6464
9201 INDUSTRIAL BLVD. SE DECISION MADE: 17-OCT-08
LELAND, NC 28451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMAPROBE
CLAREBLEND, INC. 510(k) NO: K073000(TRADITIONAL)
ATTN: JILL CREASY PHONE NO : 847-429-9631
675 PINE STREET SE DECISION MADE: 01-OCT-08
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830
CLAREBLEND, INC. 510(k) NO: K073022(TRADITIONAL)
ATTN: JILL CREASY PHONE NO : 847-429-9631
675 PINE STREET SE DECISION MADE: 01-OCT-08
ELGIN, IL 60123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
CLEARLAB SG PTE LTD. 510(k) NO: K080632(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
806 KIMBALL AVENUE SE DECISION MADE: 15-OCT-08
GRAND JUNCTION, CO 81501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MO
CNSYSTEM MEDIZINTECHNIK AG 510(k) NO: K082599(TRADITIONAL)
ATTN: SUMPER PHONE NO :
REININGHAUSSTRASSE 13 SE DECISION MADE: 17-OCT-08
GRAZ, AUSTRIA 8020 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
COLOPLAST MANUFACTURING US, LLC 510(k) NO: K082640(TRADITIONAL)
ATTN: ANGELA BYLAND PHONE NO : 612-287-4236
1499 WEST RIVER ROAD NORTH SE DECISION MADE: 17-OCT-08
MINNEAPOLIS, MN 55411 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY
CONTAMAC LTD. 510(k) NO: K081178(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
806 KIMBALL AVENUE SE DECISION MADE: 09-OCT-08
GRAND JUNCTION, CO 81501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNAMATRIX
COOK BIOTECH, INC. 510(k) NO: K082058(TRADITIONAL)
ATTN: DAVID J COLLETTE PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 02-OCT-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: COOK WIRE GUIDES
COOK UROLOGICAL, INC. 510(k) NO: K082536(TRADITIONAL)
ATTN: CINDY FOOTE PHONE NO : 812-829-4891
1100 WEST MORGAN ST. SE DECISION MADE: 27-OCT-08
SPENCER, IN 47460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR
COSMAN MEDICAL, INC. 510(k) NO: K082012(TRADITIONAL)
ATTN: LOUIS FALCONE PHONE NO : 781-272-6561
76 CAMBRIDGE ST. SE DECISION MADE: 14-OCT-08
BURLINGTON, MA 01803-4140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
COSMAN MEDICAL, INC. 510(k) NO: K082051(TRADITIONAL)
ATTN: LOUIS FALCONE PHONE NO : 781-272-6561
76 CAMBRIDGE ST. SE DECISION MADE: 16-OCT-08
BURLINGTON, MA 01803-4140 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PB 540 VENTILATOR
COVIDIEN, FORMERLY NELLCOR PURITAN510(k) NO: K082966(SPECIAL)
ATTN: TINA O'BRIEN PHONE NO : 303-305-2512
6135 GUNBARREL AVE SE DECISION MADE: 31-OCT-08
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FO
CROSSTEX INTERNATIONAL 510(k) NO: K082258(TRADITIONAL)
ATTN: RICHARD M ORMSBEE PHONE NO : 763-551-2689
14605 28TH AVENUE NORTH SE DECISION MADE: 16-OCT-08
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM
DAILIAN LATEX COMPANY, LTD. 510(k) NO: K081413(TRADITIONAL)
ATTN: PHONE NO :
NO. 188 MALAN NORTH STREET SE DECISION MADE: 24-OCT-08
SHAHEKOU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
DAILIAN CITY, LIAONING, CHINA 1160THIRD PARTY REVIEW
DEVICE: THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H8
DALE MEDICAL PRODUCTS, INC. 510(k) NO: K082241(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 30-OCT-08
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUMAO MANUAL WHEELCHAIR
DANYANG JUMAO HEALTHCARE EQUIPMENT510(k) NO: K082784(TRADITIONAL)
ATTN: QING WANG PHONE NO : 865 118 6379811
NO.89 SHUANGFENG ROAD, SE DECISION MADE: 07-OCT-08
JIEPAI TOWN 510(k) SUMMARY AVAILABLE FROM FDA
DANYANG; JIANGSU, CHINA 212323 THIRD PARTY REVIEW
DEVICE: BP LIMBO XL, BPTANGO XL, BP SALSA XL
DATADANCER MEDICAL SYSTEMS 510(k) NO: K072752(TRADITIONAL)
ATTN: MICHAEL KOHUT PHONE NO : 530-892-9086
1644 LAUREL STREET SE DECISION MADE: 31-OCT-08
CHICO, CA 95928 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENGSTROM CARESTATION, ENGSTROM PRO
DATEX-OHMEDA, INC. 510(k) NO: K081842(TRADITIONAL)
ATTN: ADRIENNE LENZ PHONE NO : 608-221-1551
P.O. BOX 7550 SE DECISION MADE: 03-OCT-08
MADISON, WI 53707 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD 3DMAX MESH
DAVOL INC., SUB. C.R. BARD, INC. 510(k) NO: K081010(TRADITIONAL)
ATTN: STEPHANIE BAKER PHONE NO : 401-215-2252
100 SOCKANOSSETT CROSSROAD SE DECISION MADE: 07-OCT-08
CRANSTON, RI 02920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VRIICU SYSTEM
DEEP BREEZE LTD. 510(k) NO: K073582(TRADITIONAL)
ATTN: JEFF BAETZ PHONE NO : 202-822-1850
2001 PENNSYLVANIA AVENUE NW SE DECISION MADE: 15-OCT-08
SUITE 950 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: DURASHIELD PLUS
DENTSPLY INTL., INC. 510(k) NO: K082198(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CENTER SE DECISION MADE: 29-OCT-08
221 W PHILADELPHIA ST. STE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: MODFICATION TO: EXPEDIUM SPINE SYSTEM
DEPUY SPINE, INC. 510(k) NO: K082942(SPECIAL)
ATTN: FRANK JURCZAK PHONE NO : 508-828-3288
325 PARAMOUNT DR. SE DECISION MADE: 31-OCT-08
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
DIAGNOSTICA STAGO, INC. 510(k) NO: K082675(SPECIAL)
ATTN: UMBERTO V PARROTTA PHONE NO : 973-631-1200
5 CENTURY DR. SE DECISION MADE: 10-OCT-08
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOURTH GAS MODULE WITH CO2 FOR PRIMUS US "APOLLO"
DRAEGER MEDICAL AG & CO. KG 510(k) NO: K081447(TRADITIONAL)
ATTN: KARIN LUEBBERS PHONE NO : 49 451 8825367
53/55 MOISLINGER ALLEE SE DECISION MADE: 08-OCT-08
LUEBECK, GERMANY 23542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIO SM IMPLANT SYSTEM
DSI, INC. 510(k) NO: K080559(TRADITIONAL)
ATTN: HYUNGICK KIM PHONE NO : 213-365-2875
3540 WILSHIRE BLVD SUITE 1104 SE DECISION MADE: 09-OCT-08
LOS ANGELES, CA 90010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786
DUCKWORTH & KENT, LTD. 510(k) NO: K081382(TRADITIONAL)
ATTN: MARTIN LOCK PHONE NO : 011 441 462893254
7 MARQUIS BUSINESS CENTRE SE DECISION MADE: 23-OCT-08
ROYSTON RD. 510(k) SUMMARY AVAILABLE FROM FDA
BALDOCK, HERTSFORDSHIRE, UNITED KINGDOM SG7 6XL
DEVICE: MASTER3DS
E-WOO TECHNOLOGY 510(k) NO: K082410(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-9093
340 SHADY GROVE ROAD SE DECISION MADE: 31-OCT-08
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: URESTA PESSARY
EASTMED INC. 510(k) NO: K081385(TRADITIONAL)
ATTN: SHIRLEY FURESZ PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 09-OCT-08
DUNDAS, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
EDWARDS LIFESCIENCES, LLC. 510(k) NO: K082139(TRADITIONAL)
ATTN: DARYL RICHARDSON PHONE NO : 949-250-5036
ONE EDWARDS WAY SE DECISION MADE: 23-OCT-08
IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOR LCD MONITOR
EIZO NANAO CORPORATION 510(k) NO: K082663(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 762 742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 06-OCT-08
HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
ELCAM MEDICAL A.C.A.L. 510(k) NO: K082106(SPECIAL)
ATTN: TALI HAZAN PHONE NO : 972 4 6988875
KIBBUTZ BAR-AM SE DECISION MADE: 02-OCT-08
D.N. MEROM HAGALIL, ISRAEL 13860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABC SYRINGE INFUSION PUMP, MODEL 4100
ELIXIR CORPORATION 510(k) NO: K072603(TRADITIONAL)
ATTN: WILLIAM M VONDERSMITH PHONE NO : 770-904-3766
3700 NAMASCO DRIVE SE DECISION MADE: 23-OCT-08
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
SUWANEE, GA 30024
DEVICE: ELLIPSE MULTIFLEX
ELLIPSE A/S 510(k) NO: K081408(TRADITIONAL)
ATTN: OLE KOFOD PHONE NO : 45 457 68808
AGERN ALLE 11 SE DECISION MADE: 17-OCT-08
HOERSHOLM, DENMARK DK-2070 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTA-CLOT, INSTA-CLOT OTC
EMERGENCY MEDICAL DEVICES, LLC 510(k) NO: K082601(TRADITIONAL)
ATTN: JACK MENTKOW PHONE NO : 561-793-9773
1875 TULIP LANE SE DECISION MADE: 09-OCT-08
WELLINGTON, FL 33414 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
ENCORE MEDICAL, L.P. 510(k) NO: K082398(SPECIAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 15-OCT-08
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRACHEOSCOPIC VENTILATION TUBE (TVT)
ETVIEW 510(k) NO: K082420(SPECIAL)
ATTN: YORAM LEVY PHONE NO : 972 463 88837
31 HAAVODA ST SE DECISION MADE: 08-OCT-08
BINYAMINA, ISRAEL 30500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER T
EXACTECH, INC. 510(k) NO: K082702(SPECIAL)
ATTN: SHING JEN TAI PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 10-OCT-08
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROLINK IP, MODEL PK1113
EXCEL-TECH LTD. (XLTEK) 510(k) NO: K081741(TRADITIONAL)
ATTN: GOLDY SINGH PHONE NO : 905 829 5300
2568 BRISTOL CIR. SE DECISION MADE: 31-OCT-08
OAKVILLE, ONTARIO, CANADA L6H 5S1 510(k) STATEMENT
DEVICE: FIRMGRIP
FLEXICATH LTD. 510(k) NO: K080793(TRADITIONAL)
ATTN: TALI HAZAN PHONE NO : 972 485 00076
120 YIGAL ALON ST., SUITE 107 SE DECISION MADE: 16-OCT-08
TEL AVIV, ISRAEL 67443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWMEDICA BENEPHIT INFUSION SYSTEMS
FLOWMEDICA, INC. 510(k) NO: K082163(TRADITIONAL)
ATTN: JEFF ELKINS PHONE NO : 510-252-9500
46563 FREMONT BLVD. SE DECISION MADE: 29-OCT-08
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTIFLUX F250NR, MODEL 0500325E
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K082414(TRADITIONAL)
ATTN: JANET KAY PHONE NO : 781-699-4475
920 WINTER STREET SE DECISION MADE: 28-OCT-08
WALTHAM, MA 02451-1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE,
GALEMED CORP. 510(k) NO: K082092(TRADITIONAL)
ATTN: THOMAS LOESCHER PHONE NO : 760-930-4025
54431 AVENIDA ENCINAS SE DECISION MADE: 15-OCT-08
SUITE G 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 90228-4411
DEVICE: GRADIA CORE
GC AMERICA, INC 510(k) NO: K082171(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-897-4042
3737 W. 127TH STREET SE DECISION MADE: 30-OCT-08
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: G-BOND PLUS
GC AMERICA, INC. 510(k) NO: K082768(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-897-4042
3737 WEST 127TH ST. SE DECISION MADE: 21-OCT-08
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GE LIGHTSPEED 7.2 CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K082761(TRADITIONAL)
ATTN: TRACEY ORTIZ PHONE NO : 262-544-3026
3000 N GRANDVIEW BLVD. SE DECISION MADE: 08-OCT-08
W-1140 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM
GE MEDICAL SYSTEMS, LLC 510(k) NO: K082816(TRADITIONAL)
ATTN: STEVEN KACHELMEYER PHONE NO : 262-548-2432
3000 N GRANDVIEW BLVD. SE DECISION MADE: 08-OCT-08
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GE XTREME INJECTOR OPTION
GE MEDICAL SYSTEMS, LLC 510(k) NO: K082960(TRADITIONAL)
ATTN: STEVEN KACHELMEYER PHONE NO : 262-548-2432
3000 N GRANDVIEW BLVD. SE DECISION MADE: 17-OCT-08
W706 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: MODIFICATION TO MICROFUSE BONE VOID FILLER
GLOBUS MEDICAL, INC. 510(k) NO: K082442(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 07-OCT-08
VALLEY FORGE BUSINESS CENTER 510(k) SUMMARY AVAILABLE FROM FDA
AUDUBON, PA 19403
DEVICE: MODIFICATION TO ZENIEVA
GORBEC PHARMACEUTICAL SERVICES, IN510(k) NO: K082865(SPECIAL)
ATTN: SANDRA R KIRCUS PHONE NO : 919-281-4080
2445 SOUTH ALSTON AVENUE SE DECISION MADE: 23-OCT-08
DURHAM, NC 27713 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLASH N' GO
HOME SKINOVATIONS LTD. 510(k) NO: K082298(TRADITIONAL)
ATTN: AMIR WALDMAN PHONE NO : 972 4 9097440
APOLO BUILDING SE DECISION MADE: 23-OCT-08
POB 533 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM, ISRAEL 20692
DEVICE: ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
HORIBA ABX 510(k) NO: K073309(TRADITIONAL)
ATTN: OLIVIER DUCAMP PHONE NO : 33 467 147392
PARC EUROMEDECINE SE DECISION MADE: 17-OCT-08
RUE DU CADUCEE, BP 7290 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, FRANCE 34184
DEVICE: GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWA
HOSPIRA, INC. 510(k) NO: K083019(TRADITIONAL)
ATTN: YULIYA MATLIN PHONE NO : 224-212-4857
275 NORTH FIELD DR. SE DECISION MADE: 22-OCT-08
DEPT. 389, BLDG. H2 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045 THIRD PARTY REVIEW
DEVICE: STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
HOWMEDICA OSTEONICS CORP 510(k) NO: K082567(SPECIAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 03-OCT-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: T2 FLEXIBLE NAIL
HOWMEDICA OSTEONICS CORP. 510(k) NO: K082018(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DRIVE SE DECISION MADE: 10-OCT-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMARTSIGNS MINPULSE
HUNTLEIGH HEALTHCARE LTD. 510(k) NO: K081572(TRADITIONAL)
ATTN: ROBERT MCCARTHY PHONE NO : 442 920 485885
35 PORTMANMOOR RD. SE DECISION MADE: 01-OCT-08
CARDIFF, SOUTH GLAMORGAN, UNITED K510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MOD
I-SENS, INC. 510(k) NO: K080923(TRADITIONAL)
ATTN: HYUN JOON OH PHONE NO : 822 916 6191
465-6 WOLGYE-DONG, NOWON-GU SE DECISION MADE: 17-OCT-08
SEOUL, REPUBLIC OF KOREA 139-845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM
IASIS MEDICAL, INC. 510(k) NO: K080275(TRADITIONAL)
ATTN: JOHN BUAN PHONE NO : 612-703-1204
6393 OAKGREEN AVENUE SE DECISION MADE: 09-OCT-08
HASTINGS, MN 55033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
IKONISYS INC 510(k) NO: K080909(TRADITIONAL)
ATTN: SYED ATAULLAH PHONE NO : 203-776-0791
5 SCIENCE PARK SE DECISION MADE: 17-OCT-08
SUITE 1000 510(k) SUMMARY AVAILABLE FROM FDA
NEW HAVEN, CT 06511
DEVICE: OSDX HIP BMD SYSTEM
IMAGING THERAPEUTICS, INC. 510(k) NO: K082402(TRADITIONAL)
ATTN: PATRICK HESS PHONE NO : 650-286-4166
400 SEAPORT COURT, SUITE 250 SE DECISION MADE: 16-OCT-08
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
IMPEDIMED PTY LTD. 510(k) NO: K080825(TRADITIONAL)
ATTN: PHILIP S AUCKLAND PHONE NO : 61 7 34231777
UNIT 1, 50 PARKER COURT SE DECISION MADE: 03-OCT-08
PINKENBA, QLD, AUSTRALIA 4008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
INNERCOOL THERAPIES, INC.- A DELAW510(k) NO: K080908(SPECIAL)
ATTN: JENNIFER SPINELLA PHONE NO : 858-436-1016
6740 TOP GUN STREET SE DECISION MADE: 17-OCT-08
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE OMP PLUS ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K081248(TRADITIONAL)
ATTN: ZAKERA SHUMS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 27-OCT-08
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS
INSTITUT STRAUMANN AG 510(k) NO: K082545(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 17-OCT-08
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN WN CARES TITANIUM ABUTMENT
INSTITUT STRAUMANN AG 510(k) NO: K082764(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 01-OCT-08
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAYFIELD MR/X-RAY SKULL CLAMP
INTEGRA LIFESCIENCES CORP. 510(k) NO: K081401(SPECIAL)
ATTN: HELDER A SOUSA PHONE NO : 609-936-6850
311 ENTERPRISE DR. SE DECISION MADE: 08-OCT-08
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AURAGEN CORTICAL SURFACE ELECTRODES
INTEGRA NEUROSCIENCES 510(k) NO: K082250(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 609-936-2495
311 ENTERPRISE DR. SE DECISION MADE: 10-OCT-08
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HRB-127-32 HIGH RESOLUTION BRAIN COIL
INVIVO 510(k) NO: K082916(SPECIAL)
ATTN: JEFF WILKINSON PHONE NO : 352-336-0010
3545 S.W. 47TH AVE. SE DECISION MADE: 15-OCT-08
GAINESVILLE, FL 32608 510(k) STATEMENT
DEVICE: APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
ISODOSE CONTROL B.V. 510(k) NO: K082530(ABBREVIATED)
ATTN: HUB VAN DE BERGH PHONE NO : 31 318 502950
MAXWELLSTRAAT 16 SE DECISION MADE: 30-OCT-08
EDE, NETHERLANDS 6716 BX 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
K2M, INC. 510(k) NO: K081107(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 10-OCT-08
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K082046(TRADITIONAL)
ATTN: MONIKA CAMPBELL PHONE NO : 310-338-8100
600 CORPORATE POINTE SE DECISION MADE: 10-OCT-08
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KOWA NONMYD ALPHA-DIII
KOWA CO. LTD. 510(k) NO: K082767(SPECIAL)
ATTN: AKIHIRO FUJITA PHONE NO : 81 3 56238049
4-14, NIHONBASHI-HONCHO SE DECISION MADE: 21-OCT-08
3-CHOME 510(k) SUMMARY AVAILABLE FROM FDA
CHUO-KU, TOKYO, JAPAN 103-8433
DEVICE: KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530
KRELL PRECISION (YANG ZHOU) CO., L510(k) NO: K081587(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093
340 SHADY GROVE RD. SE DECISION MADE: 24-OCT-08
FLINTVILLE, TN 37335-5031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KYMCO FORU, MODEL EQ10
KWANG YANG MOTOR CO., LTD. 510(k) NO: K082900(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2, NO.1, ZHUANGJING ROAD SE DECISION MADE: 28-OCT-08
LANE 25 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: KYMCO FORU, MODEL EQ20
KWANG YANG MOTOR CO., LTD. 510(k) NO: K082901(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2, NO.1, ZHUANGJING ROAD SE DECISION MADE: 28-OCT-08
LANE 25 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: POLYBONE GRANULE & BLOCK
KYUNGWON MEDICAL CO., LTD. 510(k) NO: K082338(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562-404-8466
13340 EAST FIRESTONE BLVD. SE DECISION MADE: 16-OCT-08
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
LANX, LLC 510(k) NO: K082774(TRADITIONAL)
ATTN: ALAN BURKHOLDER PHONE NO : 303-443-7500
390 INTERLOCKEN CRESCENT SE DECISION MADE: 21-OCT-08
SUITE 890 510(k) SUMMARY AVAILABLE FROM FDA
BROOMFIELD, CO 80021
DEVICE: LDR SPINE EASYSPINE SYSTEM
LDR SPINE USA 510(k) NO: K082592(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-344-3319
4030 WEST BRAKER LANE SE DECISION MADE: 08-OCT-08
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78759
DEVICE: MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTR
LEARNING CURVE BRANDS INC. THE FIR510(k) NO: K082802(TRADITIONAL)
ATTN: SUPRAVAN KHONGKRUAPHAN PHONE NO : 781-341-6250
100 TECHNOLOGY CTR. DR. SE DECISION MADE: 09-OCT-08
SUITE 2A 510(k) SUMMARY AVAILABLE FROM FDA
STOUGHTON, MA 02072 THIRD PARTY REVIEW
DEVICE: LEVO C3
LEVO AG 510(k) NO: K083017(TRADITIONAL)
ATTN: THOMAS RABER PHONE NO : 41 56 6184411
ANGLIKERSTRASSE 20 SE DECISION MADE: 24-OCT-08
5610 WOHLEN, SWITZERLAND CH-5610 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PL
LIFE-TECH, INC. 510(k) NO: K082923(SPECIAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600
4235 GREENBRIAR DR. SE DECISION MADE: 24-OCT-08
STAFFORD, TX 77477-3995 510(k) STATEMENT
DEVICE: LTM WOUND DRESSING
LIFECELL CORP. 510(k) NO: K082103(TRADITIONAL)
ATTN: MANAL MORCOS PHONE NO : 908-947-1131
ONE MILLENNIUM WAY SE DECISION MADE: 08-OCT-08
BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
LIFENET HEALTH 510(k) NO: K081438(TRADITIONAL)
ATTN: ALYCE LINTHURST JONES PHONE NO : 757-609-4359
1864 CONCERT DR. SE DECISION MADE: 17-OCT-08
VIRGINIA BEACH, VA 23453 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K082513(SPECIAL)
ATTN: OYINKAN DONALDSON PHONE NO : 011 441 463721259
BEECHWOOD PARK NORTH SE DECISION MADE: 22-OCT-08
INVERNESS, SCOTLAND, UNITED KINGDO510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HELONTIX VENT
LINDE GAS THERAPEUTICS 510(k) NO: K072926(TRADITIONAL)
ATTN: ANN-CATHRIN JAREMAN PHONE NO : 468 731 1031
AGA AB SE DECISION MADE: 15-OCT-08
SE-181 81LIDINGO, SWEDEN 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LBI EMBOLECTOMY SYSTEM
LUMEN BIOMEDICAL, INC. 510(k) NO: K080901(TRADITIONAL)
ATTN: MARIA E BRITTLE PHONE NO : 763-746-9550
14505 21ST AVE. NORTH SE DECISION MADE: 02-OCT-08
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: POWERLIPO LASER SYSTEM
LUTRONIC CORPORATION 510(k) NO: K082096(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 08-OCT-08
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAJOR.BASE 20
MAJOR PRODOTTI DENTARI S.P.A. 510(k) NO: K081884(ABBREVIATED)
ATTN: MONICA FUNAI PHONE NO : 39 011 6400211
VIA LUIGI EINAUDI 23 SE DECISION MADE: 08-OCT-08
MONACALIERI (TORINO), ITALY I-1002510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III
MAKO SURGICAL CORP. 510(k) NO: K082081(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2555 DAVIE RD. SE DECISION MADE: 15-OCT-08
FORT LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
MAKO SURGICAL CORP. 510(k) NO: K082088(TRADITIONAL)
ATTN: WILLIAM F TAPIA PHONE NO : 954-927-2044
2555 DAVIE RD. SE DECISION MADE: 22-OCT-08
FORT LAUDERDALE, FL 33317 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
MALLINCKRODT DEVELOPPEMENT FRANCE 510(k) NO: K082237(SPECIAL)
ATTN: TINA DREILING PHONE NO : 303-305-2512
6135 GUNBARREL AVE. SE DECISION MADE: 09-OCT-08
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES
MALLINCKRODT MEDICAL 510(k) NO: K082520(SPECIAL)
ATTN: SCOTT D DICKERHOFF PHONE NO : 303-305-2382
6135 GUNBARREL AVE. SE DECISION MADE: 02-OCT-08
BOULDER, CO 80301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUART ARTERIAL FILTER WITH BIOLINE COATING
MAQUET CARDIOPULMONARY AG 510(k) NO: K082544(SPECIAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 49 747 8921151
HECHINGER STRASSE 38 SE DECISION MADE: 03-OCT-08
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRDH BANDAGE
MARINE POLYMER TECHNOLOGIES, INC. 510(k) NO: K082703(TRADITIONAL)
ATTN: SERGIO FINKIELSZTEIN PHONE NO : 781-270-3200
107 WATER ST. SE DECISION MADE: 14-OCT-08
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57
MASIMO CORPORATION 510(k) NO: K082052(TRADITIONAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 10-OCT-08
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARAPASTE ORAL WOUND DRESSING
MCGRATH PHARMACEUTICALS, INC. 510(k) NO: K082856(TRADITIONAL)
ATTN: PATRICK D MCGRATH PHONE NO : 847-548-7860
683 CENTER STREET SE DECISION MADE: 15-OCT-08
UNIT C 510(k) SUMMARY AVAILABLE FROM FDA
GRAYSLAKE, IL 60030
DEVICE: EVOLIS TOTAL KNEE SYSTEM
MEDACTA INTERNATIONAL, SA 510(k) NO: K081023(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 22-OCT-08
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTO-SAFETY INJECTOR-2 (ASI-2)
MEDICAL HOUSE PRODUCTS LIMITED 510(k) NO: K082587(TRADITIONAL)
ATTN: ROSE Y GUANG PHONE NO : 441 142 619011
199 NEWHALL ROAD SE DECISION MADE: 02-OCT-08
SHEFFIELD, UNITED KINGDOM S9 2QJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUMINEX INFRARED LAMP SYSTEM
MEDICAL LASER SYSTEMS INC 510(k) NO: K082969(TRADITIONAL)
ATTN: MIKI KOLTON PHONE NO : 212-331-3134
2101 L STREET NW SE DECISION MADE: 23-OCT-08
WASHINGTON, DC 20037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND M
MEDICATECH USA 510(k) NO: K082798(SPECIAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 28-OCT-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS 2 SPINAL SYSTEM
MEDICREA TECHNOLOGIES 510(k) NO: K082069(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 03-OCT-08
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP SPINAL SYSTEM
MEDICREA TECHNOLOGIES 510(k) NO: K082577(SPECIAL)
ATTN: J D WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD SE DECISION MADE: 03-OCT-08
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENS/EMS COMBO, EMS, TENS
MEDIHIGHTEC MEDICAL CO., LTD. 510(k) NO: K082514(TRADITIONAL)
ATTN: MU-SHENG HUNG PHONE NO : 886 224 519988
4F, NO.180, FU 1ST ST., SE DECISION MADE: 21-OCT-08
CIDU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
KEELUNG CITY, CHINA (TAIWAN) 20650THIRD PARTY REVIEW
DEVICE: RTX RESPIRATOR
MEDIVENT LIMITED 510(k) NO: K082657(TRADITIONAL)
ATTN: SHAHAR HAYEK PHONE NO : 448 703 005527
MARYLAND HOUSE, 10 THE DOWNAGE SE DECISION MADE: 08-OCT-08
LONDON, ENGLAND, UNITED KINGDOM NW510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE
MEDLINE INDUSTRIES, INC. 510(k) NO: K081594(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847-643-4785
ONE MEDLINE PL. SE DECISION MADE: 17-OCT-08
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: P3T ABDOMEN
MEDRAD, INC. 510(k) NO: K082458(TRADITIONAL)
ATTN: FORTUNATO ALDAPE PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 17-OCT-08
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
MEDSOURCE INTERNATIONAL, LLC. 510(k) NO: K080339(TRADITIONAL)
ATTN: HOWARD T COOPER PHONE NO : 317-826-4398
11715 FOX ROAD SE DECISION MADE: 27-OCT-08
SUITE 400-180 510(k) SUMMARY AVAILABLE FROM FDA
INDIANAPOLIS, IN 46236
DEVICE: CD HORIZON SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K082236(SPECIAL)
ATTN: BRAD SHEALS PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 10-OCT-08
MEMPHIS, TN 38132-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CAPSTONE SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K082732(SPECIAL)
ATTN: CHRIS MCKEE PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 16-OCT-08
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYS
MEDTRONIC XOMED, INC. 510(k) NO: K081475(TRADITIONAL)
ATTN: ANTOINE KOUCHAKJY PHONE NO : 904-296-9600
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 17-OCT-08
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LA
MEDX ELECTRONICS, INC. 510(k) NO: K082707(TRADITIONAL)
ATTN: ANITA SALTMARCHE PHONE NO : 888 363 3112
3350 RIDGEWAY DR. UNIT #3 SE DECISION MADE: 01-OCT-08
MISSISSAUGA, ONTARIO, CANADA L5L 5510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: E-Z CLEAN ELECTROSURGICAL ELECTRODE
MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K081791(TRADITIONAL)
ATTN: RONDA K MAGNESON PHONE NO : 801-576-9669
11506 SOUTH STATE ST. SE DECISION MADE: 21-OCT-08
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LYMPHA PRESS OPTIMAL, MODEL# 1201AP
MEGO AFEK AC LTD 510(k) NO: K082149(TRADITIONAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002
20 HATA'AS ST. SE DECISION MADE: 06-OCT-08
KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRELUDE SHORT SHEATH INTRODUCER
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K082063(TRADITIONAL)
ATTN: JERRIE HENDRICKSON PHONE NO : 801-253-1600
1600 WEST MERIT PKWY. SE DECISION MADE: 15-OCT-08
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MO
MICROLIFE INTELLECTUAL PROPERTY GM510(k) NO: K082357(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SE DECISION MADE: 29-OCT-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: ML830TP
MICROLIGHT CORPORATION OF AMERICA 510(k) NO: K080786(TRADITIONAL)
ATTN: FRED A SIMPSON PHONE NO : 713-752-4248
2935 HIGHLAND LAKES DR. SE DECISION MADE: 03-OCT-08
MISSOURI CITY, TX 77459-4218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,1
MICROVENTION, INC. 510(k) NO: K082461(SPECIAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-461-3314
75 COLUMBIA SE DECISION MADE: 02-OCT-08
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCOIL DELIVERY SYSTEM
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K082739(SPECIAL)
ATTN: PATRICK LEE PHONE NO : 408-433-1428
821 FOX LANE SE DECISION MADE: 17-OCT-08
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MPOWRX SNORING SOLUTION
MPOWRX HEALTH AND WELLNESS PRODUCT510(k) NO: K081965(TRADITIONAL)
ATTN: JEAN ASQUITH PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY. SE DECISION MADE: 27-OCT-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATR
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K080399(TRADITIONAL)
ATTN: NANCY B JOY PHONE NO : 732-661-0202
125 MAY ST, STE 300 SE DECISION MADE: 10-OCT-08
EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA
EDISON, NJ 08837
DEVICE: MEDICAL DISPLAY, MD205MG-1
NEC DISPLAY SOLUTIONS, LTD. 510(k) NO: K082493(TRADITIONAL)
ATTN: SHUICHI KINO PHONE NO : 81 465 852376
686-1 NISHIOI, OI-MACHI SE DECISION MADE: 23-OCT-08
ASHIGARAKAMI-GUN, KANAGAWA, JAPAN 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEOMED POLYURETHANE FEEDING TUBE
NEOMED, INC. 510(k) NO: K082238(SPECIAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678-428-6978
717 LAKEGLEN DR. SE DECISION MADE: 01-OCT-08
SUWANEE, GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XR-EXPRESS
NEW MEXICO SOFTWARE, INC. 510(k) NO: K082336(TRADITIONAL)
ATTN: NEAL KOLBER PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY. SE DECISION MADE: 15-OCT-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: SEN-4100 ELECTRIC STIMULATOR
NIHON KOHDEN AMERICA, INC. 510(k) NO: K071969(TRADITIONAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 06-OCT-08
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO SAFETOUCH HUBER INFUSTION SET
NIPRO MEDICAL CORP. 510(k) NO: K081210(TRADITIONAL)
ATTN: JESSICA OSWALD PHONE NO : 305-599-7174
3150 NW 107TH AVE. SE DECISION MADE: 21-OCT-08
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMDX ANALYZER, IMDXPREP REAGENT PLATE, IMDXPREP CALIBRATION PLAT
NOVX SYSTEMS INC. 510(k) NO: K080057(TRADITIONAL)
ATTN: THOMAS TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 31-OCT-08
ROCKVILLE, MD 20853 510(k) STATEMENT
DEVICE: MULLINS-X, MODEL 250X
NUMED, INC. 510(k) NO: K082868(SPECIAL)
ATTN: NICHELLE LAFLESH PHONE NO : 315-328-4491
2880 MAIN ST. SE DECISION MADE: 24-OCT-08
HOPKINTON, NY 12965 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE COROENT SYSTEM
NUVASIVE, INC. 510(k) NO: K081611(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
7475 LUSK BLVD SE DECISION MADE: 02-OCT-08
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUVASIVE SPHERX SYSTEM
NUVASIVE, INC. 510(k) NO: K082332(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
7475 LUSK BLVD SE DECISION MADE: 10-OCT-08
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NXSTAGE PUREFLOW SL
NXSTAGE MEDICAL, INC. 510(k) NO: K080919(TRADITIONAL)
ATTN: MICHAEL DOYLE PHONE NO : 978-687-4746
439 SOUTH UNION ST., 5TH FLOOR SE DECISION MADE: 15-OCT-08
LAWRENCE, MA 01843 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VB IMAGE VIEWER
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K080581(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-836-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 16-OCT-08
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034
DEVICE: XCHF-T160 VIDEOSCOPE
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K082576(TRADITIONAL)
ATTN: STACY A KLUESNER PHONE NO : 484-896-5405
3500 CORPORATE PARKWAY SE DECISION MADE: 21-OCT-08
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: HEM-9000AI
OMRON HEALTHCARE, INC. 510(k) NO: K081654(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 10-OCT-08
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
OMRON HEALTHCARE, INC. 510(k) NO: K082812(SPECIAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
24301 WOODSAGE DRIVE SE DECISION MADE: 22-OCT-08
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPORARY TOOTH REPLACEMENT
ORMCO CORP. 510(k) NO: K081900(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714-516-7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 24-OCT-08
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CURATIVE980 DIODE LASER
OROSCIENCE, INC. 510(k) NO: K082445(TRADITIONAL)
ATTN: PHIL HOULE PHONE NO : 650-315-7538
2275 EAST BAYSHORE ROAD SE DECISION MADE: 15-OCT-08
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94303 THIRD PARTY REVIEW
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATOR
ORTHO-CLINICAL DIAGNOSTICS, INC. 510(k) NO: K081543(SPECIAL)
ATTN: LEAH VAN DE WATER PHONE NO : 585-453-4131
100 INDIGO CREEK DRIVE SE DECISION MADE: 23-OCT-08
MC881 510(k) SUMMARY AVAILABLE FROM FDA
ROCHESTER, NY 14626-5101
DEVICE: STARLIGHT
ORTHOMERICA PRODUCTS, INC. 510(k) NO: K082945(SPECIAL)
ATTN: ALAN T SANDIFER PHONE NO : 407-290-6592
6333 NORTH ORANGE BLOSSOM SE DECISION MADE: 31-OCT-08
TRAIL 510(k) STATEMENT
ORLANDO, FL 32810
DEVICE: ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
ORTHOPEDIATRICS, CORP. 510(k) NO: K082375(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379
210 N. BUFFALO ST. SE DECISION MADE: 17-OCT-08
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GS III FIXTURE SYSTEM
OSSTEM IMPLANT CO.,LTD 510(k) NO: K082213(SPECIAL)
ATTN: MINJOO KIM PHONE NO : 267-759-7044
85 BEN FAIRLESS DR SE DECISION MADE: 14-OCT-08
FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBAB
OSTEOTECH INC 510(k) NO: K082615(TRADITIONAL)
ATTN: CHRIS TALBOT PHONE NO : 732-542-2800
51 JAMES WAY SE DECISION MADE: 16-OCT-08
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ICON, MODEL C3
OSYPKA MEDICAL, INC. 510(k) NO: K082242(SPECIAL)
ATTN: MARKUS OSYPKA PHONE NO : 858-454-0021
7855 IVANHOE AVE., SUITE 226 SE DECISION MADE: 08-OCT-08
LA JOLLA, CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRAVORACER PEDIATRIC MANUAL WHEELCHAIR
OTTO BOCK HEALTH CARE, LP 510(k) NO: K082314(TRADITIONAL)
ATTN: WILLIAM JACKSON PHONE NO : 651-773-0002
2247 JENNIFER LANE SE DECISION MADE: 28-OCT-08
ST PAUL, MN 55109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: P & F POWER WHEELCHAIR, MODEL HC-500SB
P&F BROTHER IND.,CORP 510(k) NO: K082722(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO.58, FU-CHIUN ST. SE DECISION MADE: 28-OCT-08
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF THE
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K082164(TRADITIONAL)
ATTN: CHRISTIAN G QUASS PHONE NO : 49 770 49291
KARL-HALL-STRASSE 01 SE DECISION MADE: 27-OCT-08
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K082183(TRADITIONAL)
ATTN: CHRISTIAN G. H. QUASS PHONE NO : 49 770 49291586
KARL-HALL-STRASSE 1 SE DECISION MADE: 28-OCT-08
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSTREAM PATHWAY PV ATHERECTOMY SYSTEM, MODEL PV10300, PVCN100
PATHWAY MEDICAL TECHNOLOGIES, INC.510(k) NO: K082664(SPECIAL)
ATTN: KEN PERINO PHONE NO : 425-636-4152
10801 120TH AVENUE NE SE DECISION MADE: 06-OCT-08
KIRKLAND, WA 98033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEURON DELIVERY CATHETER 070
PENUMBRA, INC. 510(k) NO: K082290(SPECIAL)
ATTN: THERESA BRANDNER-ALLEN PHONE NO : 510-748-3223
1351 HARBOR BAY PKWY. SE DECISION MADE: 31-OCT-08
ALAMEDA, CA 94502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K082280(SPECIAL)
ATTN: MARY KRUITWAGEN PHONE NO : 978-659-4932
22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 08-OCT-08
BOTHELL, WA 98021-8431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS MP5 AND MP5T INTELLIVUE PATIENT MONITORS AND TRX4841A IN
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K081793(SPECIAL)
ATTN: MARKUS STACHA PHONE NO : 49 703 14632840
HEWLETT-PACKARD STR.2 SE DECISION MADE: 14-OCT-08
BOEBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP2
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K082633(SPECIAL)
ATTN: ANDREAS SUCHI PHONE NO : 497 031 4631291
HEWLETT-PACKARD STR.2 SE DECISION MADE: 03-OCT-08
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
PHOTOMEDEX, INC. 510(k) NO: K082721(TRADITIONAL)
ATTN: ALFRED INTINTOLI PHONE NO : 215-619-3600
147 KEYSTONE DR. SE DECISION MADE: 28-OCT-08
MONTGOMERYVILLE, PA 18936 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIVOT ASSIST
PIVOT ASSIST, LLC 510(k) NO: K081053(TRADITIONAL)
ATTN: JOHN QUIGLEY PHONE NO : 216-650-8731
9335 MCCRACKEN BLVD. SE DECISION MADE: 09-OCT-08
GARFIELD HTS., OH 44125 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRIND NO MORE
PLACONTROL INC. 510(k) NO: K082301(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET NW SE DECISION MADE: 06-OCT-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISION OXYGEN CONCENTRATOR
PRECISION MEDICAL, INC. 510(k) NO: K072348(ABBREVIATED)
ATTN: JAMES PARKER PHONE NO : 610-262-6090
300 HELD DR. SE DECISION MADE: 27-OCT-08
NORTHAMPTON, PA 18067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIG
PRIMARY CARE SOLUTIONS, INC. 510(k) NO: K082330(TRADITIONAL)
ATTN: RON MADDIX PHONE NO : 813-779-7226
40420 FREE FALL AVE. SE DECISION MADE: 09-OCT-08
ZEPHYRHILLS, FL 33542 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
PRINCETON BIOMEDITECH CORP. 510(k) NO: K082661(SPECIAL)
ATTN: KYUNG-AH KIM PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 06-OCT-08
MONMOUTH JUNCTION, NJ 08852-1905 510(k) STATEMENT
DEVICE: PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER
PROMEDICAL PRODUCTS CO., LTD. 510(k) NO: K080629(TRADITIONAL)
ATTN: LEO WEI PHONE NO : 86 519 88222111
# 206 HAUNG HE ROAD WEST SE DECISION MADE: 20-OCT-08
CHANGZHOU, JIANGSU, CHINA 213022 510(k) STATEMENT
DEVICE: RAYDOSE
RAYSEARCH LABORATORIES AB 510(k) NO: K082221(TRADITIONAL)
ATTN: ANDERS MURMAN PHONE NO : 46 8 54506157
SVEAVAGEN 25, PLAN 9 SE DECISION MADE: 22-OCT-08
STOCKHOLM, SWEDEN SE-111 34 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TEMPUSIC PATIENT MONITOR
REMOTE DIAGNOSTIC TECHNOLOGIES LTD510(k) NO: K082718(TRADITIONAL)
ATTN: CHRIS HANNAN PHONE NO : 44 125 6362400
THE AVENUE, FARLEIGH WALLOP SE DECISION MADE: 10-OCT-08
BASINGSTOKE, HAMPSHIRE, UNITED KIN510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO MIRAGE MICRO
RESMED LTD. 510(k) NO: K081321(SPECIAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 09-OCT-08
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE
RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K082447(TRADITIONAL)
ATTN: MICHELLE SHIH PHONE NO : 886 2 66003631
NO. 8, JIANG YIN ROAD SE DECISION MADE: 14-OCT-08
YI TANG TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
PIZHOU, JIANGSU, CHINA
DEVICE: MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOF
ROCHE DIAGNOSTICS 510(k) NO: K082595(SPECIAL)
ATTN: SCOTT THIEL PHONE NO : 800-428-5074
9115 HAGUE ROAD SE DECISION MADE: 28-OCT-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITRIFICATION KIT & VITRIFICATION WARMING KIT
SAGE IN-VITRO FERTILIZATION INC. 510(k) NO: K073522(TRADITIONAL)
ATTN: GRACE HOLLAND PHONE NO : 949-262-0411
3722 AVE. SAUSALITO SE DECISION MADE: 10-OCT-08
IRVINE, CA 92606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROFILE MULTI-PLATFORM SYSTEM
SCITON, INC. 510(k) NO: K081352(TRADITIONAL)
ATTN: JAY M PATEL PHONE NO : 650-493-9155
925 COMMERCIAL ST. SE DECISION MADE: 23-OCT-08
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
SHENZHEN KINGYIELD TECHNOLOGY CO.,510(k) NO: K083043(TRADITIONAL)
ATTN: DACHENG GONG PHONE NO : 86 755 27371997
FUHAI ROAD SE DECISION MADE: 27-OCT-08
FUYONG TOWN, BAOAN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENZHEN, GUANGDONG, CHINA 518103 THIRD PARTY REVIEW
DEVICE: M5 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K083001(TRADITIONAL)
ATTN: TAN CHUANBIN PHONE NO : 86 755 26582888
MINDRAY BUILDING,KEJI 12TH RD. SE DECISION MADE: 22-OCT-08
SOUTH, HI-TECH INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
NANSHAN, SHENZHEN, GUANGDONG, CHINTHIRD PARTY REVIEW
DEVICE: INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K081732(TRADITIONAL)
ATTN: KATHLEEN A DRAY-LYONS PHONE NO : 781-826-4551
500 GBC DRIVE M/S 514 SE DECISION MADE: 24-OCT-08
NEWARK, DE 19702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K082680(ABBREVIATED)
ATTN: VICTOR M CARRIO PHONE NO : 302-631-0376
MS 514, PO BOX 6101 SE DECISION MADE: 10-OCT-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CA
SIEMENS HEALTHCARE DIAGNOSTICS INC510(k) NO: K081857(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
PO BOX 6101 SE DECISION MADE: 30-OCT-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOMATOM FLASH DS
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K082220(TRADITIONAL)
ATTN: CORRINE MCLEOD PHONE NO : 610-448-1772
51 VALLEY STREAM PARKWAY SE DECISION MADE: 10-OCT-08
MS E50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355-1406
DEVICE: MAGNETOM C!
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K082331(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 01-OCT-08
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
SMART GLOVE CORP. SDN BHD 510(k) NO: K082370(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 16100
LOT 6487 BATU 5 3/4 SE DECISION MADE: 17-OCT-08
SEMENTA, JALAN KAPAR 510(k) STATEMENT
SELANGOR DARUL EHSAN, MALAYSIA 42100
DEVICE: ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
SMITH & NEPHEW ENDOSCOPY, INC. 510(k) NO: K082095(TRADITIONAL)
ATTN: KATHY REDDIG PHONE NO : 978-749-1321
150 MINUTEMAN ROAD SE DECISION MADE: 21-OCT-08
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1
SMITH & NEPHEW, INC. 510(k) NO: K082267(SPECIAL)
ATTN: RISHI SINHA PHONE NO : 901-399-6054
1450 BROOKS RD. SE DECISION MADE: 29-OCT-08
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), MODEL 100
SONOCINE, INC. 510(k) NO: K082543(TRADITIONAL)
ATTN: ROBERT J CHIN PHONE NO : 650-593-5225
5475 RENO CORPORATE DR. SE DECISION MADE: 14-OCT-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
RENO, NV 89511 THIRD PARTY REVIEW
DEVICE: ENSPLINTCMX CLAVICLE PIN
SONOMA ORTHOPEDIC PRODUCTS, INC. 510(k) NO: K081832(TRADITIONAL)
ATTN: CHARLES NELSON PHONE NO : 707-526-1335
650 LARKFIELD CENTER SE DECISION MADE: 10-OCT-08
SUITE C 510(k) SUMMARY AVAILABLE FROM FDA
SANTA ROSA, CA 95403
DEVICE: APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
SORIN GROUP ITALIA S.R.L. 510(k) NO: K083021(SPECIAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742
200 WEST STREET SE DECISION MADE: 29-OCT-08
WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL INTEGRATION SPINAL-EZE INTRAOPERATIVE EPIDURAL CATHETER K
SPINAL INTEGRATION LLC 510(k) NO: K081404(TRADITIONAL)
ATTN: TRUDIE L SEEGER PHONE NO : 407-292-4133
6314 KINGSPOINTE PKWY UNIT 6 SE DECISION MADE: 21-OCT-08
ORLANDO, FL 32819 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL USA VBR SYSTEM
SPINAL USA 510(k) NO: K081196(TRADITIONAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-420-4244
644 LAKELAND EAST DR., STE. A SE DECISION MADE: 16-OCT-08
FLOWOOD, MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
SPINE SMITH PARTNERS L.P. 510(k) NO: K082821(TRADITIONAL)
ATTN: ROBERT JONES PHONE NO : 512-206-0770
8140 N. MOPAC SE DECISION MADE: 31-OCT-08
BLDG II, SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78759
DEVICE: 6F PROXIS SYSTEM
ST. JUDE MEDICAL, INC. 510(k) NO: K073700(TRADITIONAL)
ATTN: LINH PHAM PHONE NO : 763-383-0900
6500 WEDGWOOD RD. NORTH SE DECISION MADE: 02-OCT-08
MAPLE GROVE, MN 55311 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STARR FRAME STEINMANN PIN
STARR FRAME LLC 510(k) NO: K082017(ABBREVIATED)
ATTN: FRANK GEROME PHONE NO : 214-576-9818
1302 E. COLLINS BLVD. SE DECISION MADE: 10-OCT-08
RICHARDSON, TX 75081 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRAUMANN GUIDED INSTRUMENTS
STRAUMANN USA 510(k) NO: K082532(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 800-448-8168
60 MINUTEMAN ROAD SE DECISION MADE: 21-OCT-08
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER ESSX WITH NAVIGATION MOUNT
STRYKER CORP. 510(k) NO: K080052(TRADITIONAL)
ATTN: VALERIE FRANCK PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 02-OCT-08
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER VISION ELECT WHDTV (STRYKER VE WHDTV)
STRYKER ENDOSCOPY 510(k) NO: K081995(TRADITIONAL)
ATTN: MONICA BARRETT PHONE NO : 408-754-2078
5900 OPTICAL CT. SE DECISION MADE: 02-OCT-08
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
STRYKER SPINE 510(k) NO: K082608(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201-760-8296
2 PEARL COURT SE DECISION MADE: 07-OCT-08
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVILBISS DV5M SMARTLINK SYSTEM
SUNRISE MEDICAL 510(k) NO: K082209(TRADITIONAL)
ATTN: JOSEPH E OLSAVSKY PHONE NO : 814-443-7690
100 DEVILBISS DR. SE DECISION MADE: 28-OCT-08
SOMERSET, PA 15501 510(k) STATEMENT
DEVICE: DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
SUNTECH MEDICAL, INC. 510(k) NO: K080854(ABBREVIATED)
ATTN: DAVID GALLIK PHONE NO : 919-654-2332
507 AIRPORT BOULEVARD SE DECISION MADE: 20-OCT-08
SUITE 117 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
SUTURTEK INCORPORATED 510(k) NO: K082828(SPECIAL)
ATTN: ART RANKIS PHONE NO : 508-847-5961
6 BROOKSIDE CIRCLE SE DECISION MADE: 14-OCT-08
ACTON, MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
SYSMEX AMERICA, INC. 510(k) NO: K081890(TRADITIONAL)
ATTN: CARRIE PINEDA PHONE NO : 847-996-4682
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 10-OCT-08
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ULTRA TRAK PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-455
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K082618(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 07-OCT-08
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: UNISCAN -DOA SYSTEM
TAIWAN UNISON BIOTECH, INC. 510(k) NO: K080347(TRADITIONAL)
ATTN: KUANG-PIN HSIUNG PHONE NO : 886 37 586345
3F, NO. 22, KEDUNG 3RD ROAD SE DECISION MADE: 09-OCT-08
CHUNAN, MIAOLI, CHINA (TAIWAN) 350510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED
TANGSHAN LINYUAN PLASTIC PRODUCTS 510(k) NO: K082597(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
ROOM 1606 BLDG. 1 JIANXIANG SE DECISION MADE: 24-OCT-08
YUAN NO.209 BEI SI HUAN ZHC 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: TEPHAFLEX ABSORBABLE SUTURE
TEPHA, INC. 510(k) NO: K082178(TRADITIONAL)
ATTN: MARY P LEGRAW PHONE NO : 781-357-1700
99 HAYDEN AVENUE, SE DECISION MADE: 30-OCT-08
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
LEXINGTON, MA 02421
DEVICE: K-PACK II NEEDLE - 29G THIN WALL
TERUMO EUROPE N.V. 510(k) NO: K082820(SPECIAL)
ATTN: M J AERTS PHONE NO : 32 163 81211
INTERLEUVENLAAN 40 SE DECISION MADE: 23-OCT-08
RESEARCHPARK ZONE 2 510(k) SUMMARY AVAILABLE FROM FDA
LEUVEN, BELGIUM 3001
DEVICE: PINNACLE ROII INTRODUCER SHEATH
TERUMO MEDICAL CORP. 510(k) NO: K082847(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
950 ELKTON BLVD. SE DECISION MADE: 29-OCT-08
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN
THE BINDING SITE, LTD. 510(k) NO: K081674(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
EAST TOWER, SUITE 600 SE DECISION MADE: 15-OCT-08
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: EXSUDEX WOUND DRAINAGE PUMP
THE MEDICAL COMPANY 510(k) NO: K082311(ABBREVIATED)
ATTN: HARM JAAP SMIT PHONE NO : 31 33 4650113
P.O. BOX 2116 SE DECISION MADE: 08-OCT-08
AMERSFOORT, NETHERLANDS 3800 CC 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 80
THERMOGEAR, INC. 510(k) NO: K083135(TRADITIONAL)
ATTN: WAYNE FIELDS, PHD PHONE NO : 541-412-0808
1307 MOORE ST., SUITE 804 SE DECISION MADE: 31-OCT-08
BROOKINGS, OR 97415 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K082510(TRADITIONAL)
ATTN: INGE SCHEIDT PHONE NO : 004 989 32175515
EDISONSTRASSE 6 SE DECISION MADE: 01-OCT-08
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
TORNIER 510(k) NO: K082120(TRADITIONAL)
ATTN: DAMIEN GUILLAUD PHONE NO : 003 347 6613500
161 RUE LAVOISIER SE DECISION MADE: 24-OCT-08
MONTBONNOT 510(k) SUMMARY AVAILABLE FROM FDA
SAINT-ISMIER CEDEX, FRANCE 38334
DEVICE: 4D VIEWER RADIOLOGY, MODEL USWP-100A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K082684(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 14-OCT-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: INFX-8000H, INFINIX-I
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K082830(TRADITIONAL)
ATTN: PHONE NO :
2441 MICHELLE DR. SE DECISION MADE: 10-OCT-08
TUSTIN, CA 92681-2068 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K083014(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR SE DECISION MADE: 17-OCT-08
TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TWINGUARD WITH CAPNOGRAPH ACCESSORY
TRAWAX PTY LIMITED 510(k) NO: K080527(TRADITIONAL)
ATTN: CINDY MARTIN PHONE NO : 949-495-1603
29662 AVANTE SE DECISION MADE: 31-OCT-08
LAGUNA NIGUEL, CA 92677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE VIZION
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K081520(SPECIAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 24-OCT-08
CLEVELAND, OH 44131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SHOWCASE
TRILLIUM TECHNOLOGY, INC 510(k) NO: K082135(TRADITIONAL)
ATTN: GARY J ALLSEBROOK PHONE NO : 510-388-5001
16303 PANORAMIC WAY SE DECISION MADE: 21-OCT-08
SAN LEANDRO, CA 94578-1116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
TRIMED, INC. 510(k) NO: K081348(TRADITIONAL)
ATTN: KELLI ANDERSON PHONE NO : 661-312-7150
25864 TOURNAMENT RD. SUITE A SE DECISION MADE: 17-OCT-08
VALENCIA, CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENCAGE BIPOLAR RF PROBE
TROD MEDICAL SA 510(k) NO: K082954(TRADITIONAL)
ATTN: CELINE GARCIA PHONE NO : 33 381 532243
9 AVENUE DES MONTBOUCONS SE DECISION MADE: 17-OCT-08
BESANCON, FRANCE 25000 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: UC-CARE POSITIONING SYSTEM
UC-CARE MEDICAL SYSTEMS LTD 510(k) NO: K082919(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 13TH ST., NW SE DECISION MADE: 27-OCT-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONIXTOUCH ULTRASOUND SYSTEM
ULTRASONIX MEDICAL CORPORATION 510(k) NO: K083095(TRADITIONAL)
ATTN: CHAS YU PHONE NO : 604 279 8550
130-4311 VIKING WAY SE DECISION MADE: 31-OCT-08
RICHMOND, BRITISH COLUMBIA, CANADA510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 1ML UNITRACT INSULIN SYRINGE 27G*1/2 ", 1ML UNITRACT SYRINGE 29G
UNILIFE MEDICAL SOLUTIONS LIMITED 510(k) NO: K080877(ABBREVIATED)
ATTN: MICHELLE GOW PHONE NO : 612 834 66500
LEVEL 5, 35 CLARENCE STREET SE DECISION MADE: 21-OCT-08
SYDNEY, NSW, AUSTRALIA 2000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATIENT MONITORING CABLES FOR ECG, EKG, SPO2 AND BLOOD PRESSURE
UNIMED MEDICAL SUPPLIES INC. 510(k) NO: K082959(TRADITIONAL)
ATTN: LIMING XUE PHONE NO : 86 755 26828795
NO.37, YANSHAN ROAD, SHEKOU SE DECISION MADE: 10-OCT-08
SHENZHEN, GUANGDONG, CHINA 518067 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CENTERING INTRALUMINAL APPLICATOR
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K082653(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 10-OCT-08
PALO ALTO, CA 94304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VTI INTRAOPERATIVE DOPPLER SYSTEMS
VASCULAR TECHNOLOGY INCORPORATED 510(k) NO: K082870(SPECIAL)
ATTN: DAVID L REGAN PHONE NO : 603-594-9700
12 MURPHY DR. SE DECISION MADE: 28-OCT-08
NASHUA, NH 03062 510(k) STATEMENT
DEVICE: FLOWPICC CONSOLE
VASONOVA INC. 510(k) NO: K081626(TRADITIONAL)
ATTN: SORIN GRUNWALD PHONE NO : 650-269-8444
1368 BORDEAUX DR., SUITE 100 SE DECISION MADE: 15-OCT-08
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PAX-500
VATECH CO., LTD. 510(k) NO: K082350(TRADITIONAL)
ATTN: DAVE KIM PHONE NO : 281-598-8110
256 NORTH SAM HOUSTON PKWY E. SE DECISION MADE: 10-OCT-08
SUITE 115 510(k) SUMMARY AVAILABLE FROM FDA
HOUSTON, TX 77060
DEVICE: VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
VISIONSENSE, LTD. 510(k) NO: K082667(TRADITIONAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5735
555 13TH STREET, NW SE DECISION MADE: 30-OCT-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERFADEX WITH THAM
VITROLIFE SWEDEN AB 510(k) NO: K081997(SPECIAL)
ATTN: KJELL KJORK PHONE NO : 463 172 18077
FAKTORVAGEN 13 SE DECISION MADE: 09-OCT-08
KUNGSBACKA, SWEDEN SE-434 37 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VNUS CLOSUREFAST INTRAVASCULAR CATHETER, MODELS CF7-7-60-2, CF7-
VNUS MEDICAL TECHNOLOGIES, INC. 510(k) NO: K082890(SPECIAL)
ATTN: ELIZABETH TRUJILLO PHONE NO : 408-360-7307
5799 FONTANOSO WAY SE DECISION MADE: 15-OCT-08
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EASY GLAZE
VOCO GMBH 510(k) NO: K082285(TRADITIONAL)
ATTN: THORSTEN GERKENSMEIER PHONE NO : 49 472 1719200
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 24-OCT-08
CUXHAVEN, GERMANY D-27472 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMA
VOLCANO CORPORATION 510(k) NO: K082229(SPECIAL)
ATTN: MAMTA VATS PHONE NO : 916-231-4515
2870 KILGORE RD. SE DECISION MADE: 08-OCT-08
RANCHO CORDOVA, CA 95670 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GORE TRI-LOBE BALLOON CATHETER
W. L. GORE & ASSOCIATES, INC. 510(k) NO: K081799(TRADITIONAL)
ATTN: KANU H VADODARIA PHONE NO : 928-864-4259
3450 WEST KILTIE LANE SE DECISION MADE: 03-OCT-08
FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WELL LEAD SILICONE AND LATEX FOLEY CATHETERS
WELL LEAD MEDICAL INSTRUMENTS 510(k) NO: K082815(TRADITIONAL)
ATTN: HAN GUANG YUAN PHONE NO : 862 084 758878
A4-1# JINHU INDUSTRIAL ESTATE, SE DECISION MADE: 08-OCT-08
HUALONG, PAN YU 510(k) SUMMARY AVAILABLE FROM FDA
GUANGDONG, CHINA 511434 THIRD PARTY REVIEW
DEVICE: DENSEO FAIRY
XPDENT CORP 510(k) NO: K082158(TRADITIONAL)
ATTN: CARMEN PEREZ PHONE NO : 305-233-3312
12145 SW 131 AVENUE SE DECISION MADE: 15-OCT-08
MIAMI, FL 33186 510(k) STATEMENT
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
ZIBO ZHUANGYUAN PLASTIC PRODUCTS C510(k) NO: K082822(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 108 2387441
RM.1606, BLDG.1,JIANXIANG YUAN SE DECISION MADE: 22-OCT-08
NO.209 BEI SI HUAN ZHONG RD 510(k) SUMMARY AVAILABLE FROM FDA
HAIDIAN DISTRICT, BEIJING, CHINA 100083
DEVICE: NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIM
ZIMMER GMBH 510(k) NO: K081759(TRADITIONAL)
ATTN: ERIC S PITTMAN PHONE NO : 574-371-8369
P.O. BOX 708 SE DECISION MADE: 16-OCT-08
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZONARE ULTRA ULTRASOUND SYSTEM
ZONARE MEDICAL SYSTEMS, INC. 510(k) NO: K082326(TRADITIONAL)
ATTN: LINDA J MOORE PHONE NO : 650-230-2724
420 NORTH BERNARDO AVENUE SE DECISION MADE: 08-OCT-08
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
TOTAL 510(k)s THIS PERIOD 294
TOTAL WITH SUMMARIES 275
TOTAL WITH STATEMENTS 19
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