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Medical Devices
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March 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-MAR-2008 THROUGH 31-MAR-2008
DEVICE: MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R
MEDTRONIC INC. 510(k) NO: K073324(TRADITIONAL)
ATTN: BECKY HANNACK PHONE NO : 763-514-2875
8299 CENTRAL AVENUE NE SE DECISION MADE: 13-MAR-08
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5
3A HEALTH CARE S.R.L. 510(k) NO: K072163(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245
5 TIMBER LANE SE DECISION MADE: 06-MAR-08
NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PECD-01 AND PECD QUICK-01
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K080514(SPECIAL)
ATTN: DESI W SOEGIARTO PHONE NO : 011 498 1527001169
ESPE PLATZ SE DECISION MADE: 26-MAR-08
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MOUNTABLE ENDOSCOPIC BLADE
A.M. SURGICAL, INC. 510(k) NO: K080133(TRADITIONAL)
ATTN: VINCENT PASCALE PHONE NO : 631-979-9777
290 EAST MAIN ST. SUITE 200 SE DECISION MADE: 13-MAR-08
SMITHTOWN, NY 11787 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AAP BONE PLATES AND SCREW IMPLANTS
AAP IMPLANTATE AG 510(k) NO: K072411(TRADITIONAL)
ATTN: MARC SEEGERS PHONE NO : 493 075 019192
LORENZWEG 5 SE DECISION MADE: 20-MAR-08
BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AAP CANNULATED SCREW AND DARCO HEADED SCREW
AAP IMPLANTATE AG 510(k) NO: K080101(SPECIAL)
ATTN: MARC SEEGERS PHONE NO : 49 30 75019192
LORENZWEG 5 SE DECISION MADE: 25-MAR-08
BERLIN, GERMANY 12099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVATED ASPARTATE AMINOTRANSFERASE
ABBOT LABORATORIES 510(k) NO: K071525(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1920 HURD DRIVE SE DECISION MADE: 19-MAR-08
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: FOX PLUS PTA CATHETER
ABBOTT VASCULAR-VASCULAR SOLUTIONS510(k) NO: K080264(SPECIAL)
ATTN: IVALEE COHEN PHONE NO : 408-845-0682
3200 LAKESIDE DR. SE DECISION MADE: 26-MAR-08
SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINUS SPACER
ACCLARENT, INC. 510(k) NO: K072891(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874
1525-B O'BRIEN DR. SE DECISION MADE: 19-MAR-08
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
ACCLARENT, INC. 510(k) NO: K073041(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874
1525-B O'BRIEN DR. SE DECISION MADE: 11-MAR-08
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IONTOPHORESIS SYSTEM
ACCLARENT, INC. 510(k) NO: K073276(TRADITIONAL)
ATTN: KERI YEN PHONE NO : 650-687-5874
1525-B O'BRIEN DR. SE DECISION MADE: 05-MAR-08
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX
ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K073343(TRADITIONAL)
ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100
1034 PEARL ST. SE DECISION MADE: 13-MAR-08
BROCKTON, MA 02301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS
ACUMEN MEDICAL, INC. 510(k) NO: K080500(SPECIAL)
ATTN: KEVIN MACDONALD PHONE NO : 408-530-1810
275 SANTA ANA COURT SE DECISION MADE: 13-MAR-08
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEMED STIMPAD ACU-TENS TRANSCUTANEOUS ELECTRICAL NERVE STIMULATO
AEMED, INC. 510(k) NO: K071120(TRADITIONAL)
ATTN: RALPH JUGO PHONE NO : 305-409-7791
6530 SW 49TH TERRACE SE DECISION MADE: 13-MAR-08
SOUTH MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIOX MINO
AEROCRINE AB 510(k) NO: K072816(TRADITIONAL)
ATTN: JOEL SLOMOFF PHONE NO : 202-662-4688
801 PENNSYLVANIA AVE. SE DECISION MADE: 03-MAR-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLIMMANAGER BODY COMPOSITION ANALYZER, MODELS N40 AND SM-300
AIIA COMMUNICATION INC. 510(k) NO: K073227(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 20-MAR-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
AIRISTAR TECHNOLOGIES, LLC 510(k) NO: K072185(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 27-MAR-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALICIA MENSTRUAL CUP
ALICIA INTERNATIONAL PTY LTD. 510(k) NO: K070965(TRADITIONAL)
ATTN: TOM STONE PHONE NO : 61 7 55407372
P.O. BOX 1471 SE DECISION MADE: 05-MAR-08
OXENFORD, QUEENSLAND, AUSTRALIA 42510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTABLE VENTILATOR, MODEL EPV-100
ALLIED HEALTHCARE PRODUCTS, INC. 510(k) NO: K072214(TRADITIONAL)
ATTN: WAYNE KARCHER PHONE NO : 314-771-2400
1720 SUBLETTE AVE. SE DECISION MADE: 06-MAR-08
ST. LOUIS, MO 63110 510(k) STATEMENT
DEVICE: ALMA LASER NIR MODULE
ALMA LASERS LTD. 510(k) NO: K080318(TRADITIONAL)
ATTN: TATIANA EPSTEIN PHONE NO : 011 972 46275357
HALAMISH ST. POB 3021 SE DECISION MADE: 07-MAR-08
INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
CAESAREA, ISRAEL 38900
DEVICE: CAMLOG IMPLANT SYSTEM ABUTMENTS
ALTATEC GMBH 510(k) NO: K073553(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 05-MAR-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: DBEST ONE STEP OCCULT BLOOD TEST KITS
AMERITEK USA, INC. 510(k) NO: K071242(TRADITIONAL)
ATTN: K.C. YEE PHONE NO : 425-379-2580
125 130TH ST. SE SE DECISION MADE: 06-MAR-08
EVERETT, WA 98208 510(k) STATEMENT
DEVICE: AMICAS VISION SERIES PACS, MODEL 5.5
AMICAS, INC. 510(k) NO: K073526(TRADITIONAL)
ATTN: PATRICE J.C. NEDELEC PHONE NO : 617-779-7858
20 GUEST ST. SE DECISION MADE: 12-MAR-08
BOSTON, MA 02135 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFESTYLES LUBRICATED POLYISOPRENE LATEX MALE CONDOM
ANSELL HEALTHCARE PRODUCTS LLC 510(k) NO: K070800(ABBREVIATED)
ATTN: LON D MCILVAIN PHONE NO : 334-794-4231
1635 INDUSTRIAL RD. SE DECISION MADE: 06-MAR-08
DOTHAN, AL 36303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM
APIERON, INC. 510(k) NO: K073265(TRADITIONAL)
ATTN: RICHARD LOTTI PHONE NO : 650-454-8127
155 JEFFERSON DRIVE SE DECISION MADE: 14-MAR-08
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
APPLIED MEDICAL TECHNOLOGY, INC. 510(k) NO: K073034(TRADITIONAL)
ATTN: BRIAN BAKER PHONE NO : 216-475-5577
15653 NEO PKWY. SE DECISION MADE: 14-MAR-08
CLEVELAND, OH 44128 510(k) STATEMENT
DEVICE: ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01
ARTHROCARE CORP. 510(k) NO: K080482(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 20-MAR-08
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE ORTHOWAND SURGICAL DEVICE
ARTHROCARE CORP. 510(k) NO: K080610(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 31-MAR-08
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATRICURE COOLRAIL LINEAR PEN
ATRICURE, INC. 510(k) NO: K073605(TRADITIONAL)
ATTN: ALISON GRIMALDI PHONE NO : 513-644-4228
6033 SCHUMACHER PARK DR. SE DECISION MADE: 11-MAR-08
WEST CHESTER, OH 45069 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTR
AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K072686(TRADITIONAL)
ATTN: CLAIRE DORA PHONE NO : 441 382 82000
THE TECHNOLOGY PARK SE DECISION MADE: 17-MAR-08
DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL CHAMBER TPN CONTAINER
B. BRAUN MEDICAL, INC. 510(k) NO: K073538(TRADITIONAL)
ATTN: TRACY MADDOCK PHONE NO : 610-596-2240
901 MARCON BLVD. SE DECISION MADE: 12-MAR-08
ALLENTOWN, PA 18109-9341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILS SINGLE-USE I/A HANDPIECES
BAUSCH & LOMB, INC. 510(k) NO: K073023(SPECIAL)
ATTN: NED LUCE PHONE NO : 585-338-6612
1400 NORTH GOODMAN ST. SE DECISION MADE: 12-MAR-08
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BAXANO ULTRA LOW PROFILE RONGEUR
BAXANO, INC. 510(k) NO: K080494(SPECIAL)
ATTN: SHARON ROCKWELL PHONE NO : 714-695-9269
5582 CHALON ROAD SE DECISION MADE: 04-MAR-08
YORBA LINDA, CA 92886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS,
BECKMAN COULTER, INC. 510(k) NO: K080166(SPECIAL)
ATTN: JEFFREY L KOLL PHONE NO : 952-368-7899
1000 LAKE HAZELTINE DR. SE DECISION MADE: 19-MAR-08
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 U
BECTON, DICKINSON & CO. 510(k) NO: K073589(TRADITIONAL)
ATTN: MONICA GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 05-MAR-08
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BELLA
BEEKLEY CORP. 510(k) NO: K073262(TRADITIONAL)
ATTN: MARTINE M BOUTTE PHONE NO : 800-233-5539
150 DOLPHIN RD. SE DECISION MADE: 26-MAR-08
BRISTOL, CT 06011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
BETELCARE SDN BHD 510(k) NO: K073299(TRADITIONAL)
ATTN: KENG BENG SIAH PHONE NO : 603 329 03301
LOT 3342, JALAN KERETAPI LAMA SE DECISION MADE: 05-MAR-08
7 1/2 MI OFF JALAN KAPAR 510(k) SUMMARY AVAILABLE FROM FDA
SELANGOR, DARUL EHSAN, MALAYSIA 42200
DEVICE: SLENDERTONE ENERVIVE, MODEL 561
BIO-MEDICAL REASEARCH LTD. 510(k) NO: K071666(TRADITIONAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 7743000
PARKMORE BUSINESS PARK WEST SE DECISION MADE: 12-MAR-08
GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIO BIOAQUACARE
BIOARTIFICIAL GEL TECHNOLOGIES (BA510(k) NO: K080471(TRADITIONAL)
ATTN: JONATHAN KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET, NW SE DECISION MADE: 05-MAR-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRA
BIOKIT S.A. 510(k) NO: K072036(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 34 938 6090
CAN MALE S/N SE DECISION MADE: 19-MAR-08
LLICA D'AMUNT 510(k) SUMMARY AVAILABLE FROM FDA
BARCELONA, SPAIN 08186
DEVICE: CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT
BIOMET 3I, INC. 510(k) NO: K073345(TRADITIONAL)
ATTN: PRISCILLA CARO PHONE NO : 561-776-6785
4555 RIVERSIDE DR. SE DECISION MADE: 07-MAR-08
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARALLEL-SIDED EXTENSIVELY COATED FEMORAL STEMS
BIOMET MANUFACTURING CORP. 510(k) NO: K073637(TRADITIONAL)
ATTN: ELIZABETH WRAY PHONE NO : 574-267-6639
56 EAST BELL DRIVE PO BX 587 SE DECISION MADE: 20-MAR-08
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
BIOMET, INC. 510(k) NO: K080204(TRADITIONAL)
ATTN: GARY BAKER PHONE NO : 574-267-6639
56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 20-MAR-08
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFLEX
BIOSPINE CO., LTD. 510(k) NO: K072321(TRADITIONAL)
ATTN: JUSTIN EGGLETON PHONE NO : 202-552-5800
1331 H STREET NW, 12TH FLOOR SE DECISION MADE: 25-MAR-08
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED
BIOTRONIK, INC. 510(k) NO: K072329(SPECIAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN ROAD SE DECISION MADE: 25-MAR-08
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SY
BLACKSTONE MEDICAL, INC. 510(k) NO: K080394(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838
1211 HAMBURG TURNPIKE SE DECISION MADE: 13-MAR-08
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WAYNE, NJ 07470
DEVICE: BLACKSTONE SFS PARALLEL ROD CONNECTORS
BLACKSTONE MEDICAL, INC. 510(k) NO: K080407(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838
1211 HAMBURG TURNPIKE SE DECISION MADE: 13-MAR-08
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WAYNE, NJ 07470
DEVICE: BLUE SKY BIO DENTAL IMPLANT SYSTEM
BLUE SKY BIO, LLC 510(k) NO: K073713(TRADITIONAL)
ATTN: MICHELE VOVOLKA PHONE NO : 847-548-8499
888 E BELVIDERE RD. SE DECISION MADE: 28-MAR-08
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
GRAYSLAKE, IL 60030
DEVICE: CONVOY ADVANCED DELIVERY SHEATH
BOSTON SCIENTIFIC CORP. 510(k) NO: K072719(TRADITIONAL)
ATTN: CINDY MORROW PHONE NO : 408-895-3931
2710 ORCHARD PARKWAY SE DECISION MADE: 07-MAR-08
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS 018 PERIPHERAL IMAGING CATHETER
BOSTON SCIENTIFIC CORP. 510(k) NO: K073623(TRADITIONAL)
ATTN: EMILLY TOJIMA PHONE NO : 510-624-2546
47900 BAYSIDE PARKWAY SE DECISION MADE: 13-MAR-08
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS PVIMAGING CATHETER, MODEL H749364560
BOSTON SCIENTIFIC CORP. 510(k) NO: K080272(TRADITIONAL)
ATTN: JANICE BROWN PHONE NO : 510-624-2582
47900 BAYSIDE PARKWAY SE DECISION MADE: 11-MAR-08
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
BRAHMS AKTIENGESELLSCHAFT 510(k) NO: K070310(TRADITIONAL)
ATTN: JONAS LEICHTNER PHONE NO : 410-897-9960
2568A RIVA ROAD SE DECISION MADE: 31-MAR-08
SUITE 207 510(k) SUMMARY AVAILABLE FROM FDA
ANNAPOLIS, MD 21401
DEVICE: AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP)
C.R. BARD, INC. 510(k) NO: K080170(SPECIAL)
ATTN: SKIP RIMER PHONE NO : 770-784-6160
8195 INDUSTRIAL BLVD. SE DECISION MADE: 25-MAR-08
COVINGTON, GA 30014 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUITY UNIVERSAL CUTTER
CARDIAC PACEMAKERS, INC. 510(k) NO: K080154(SPECIAL)
ATTN: KATHLEEN VITTUM PHONE NO : 651-582-4820
4100 HAMLINE AVE., NORTH SE DECISION MADE: 20-MAR-08
ST. PAUL, MN 55112-5798 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RX DC X-RAY UNIT
CEFLA S.C.R.L. 510(k) NO: K080076(TRADITIONAL)
ATTN: CLAUDE BERTOIN PHONE NO : 800-323-2690
110 E GRANADA BLVD. SE DECISION MADE: 14-MAR-08
SUITE 207 510(k) STATEMENT
ORMOND BEACH, FL 32176
DEVICE: SYSTEM PLUS
CONTINENTAL DENTAL LABORATORY 510(k) NO: K073475(TRADITIONAL)
ATTN: KAREEN CHAMBERLAIN PHONE NO : 310-618-8821
1873 WESTERN WAY SE DECISION MADE: 10-MAR-08
TORRANCE, CA 90501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMADEUS ADAPTIVE COMPRESSION THERAPY
CONVATEC 510(k) NO: K071763(TRADITIONAL)
ATTN: MARILYN KONICKY PHONE NO : 908-904-2541
200 HEADQUARTERS PARK DR. SE DECISION MADE: 07-MAR-08
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGISIS BIODESIGN TISSUE GRAFT
COOK BIOTECH, INC. 510(k) NO: K073391(TRADITIONAL)
ATTN: MARY A FADERAN PHONE NO : 765-497-3355
1425 INNOVATION PLACE SE DECISION MADE: 21-MAR-08
WEST LAFAYETTE, IN 47906 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXOR EVAC ASPIRATION CATHETER
COOK, INC. 510(k) NO: K073627(TRADITIONAL)
ATTN: KAREN BRADBURN PHONE NO : 812-339-2235
750 DANIELS WAY PO BX 489 SE DECISION MADE: 04-MAR-08
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVS TUNNELLER DEVICES
COVIDIEN UK MANUFACTURING LTD 510(k) NO: K073164(TRADITIONAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060
60 MIDDLETOWN AVENUE SE DECISION MADE: 05-MAR-08
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPULSE, MODEL I400
CYDEN LIMITED 510(k) NO: K080406(SPECIAL)
ATTN: MICHEAL KIERNAN PHONE NO : 441 792 485682
TECHNIUM, KINGS ROAD SE DECISION MADE: 10-MAR-08
THE DOCKS 510(k) SUMMARY AVAILABLE FROM FDA
SWANSEA, WALES, UNITED KINGDOM SA1 8PH
DEVICE: DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L
DADE BEHRING, INC. 510(k) NO: K073604(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
500 GBC DR, MAILSTOP 514 SE DECISION MADE: 13-MAR-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOPDECH ENDOBRONCHIAL BLOCKER TUBE, MODELS BBT-A30XXX, BBT-B30X
DAIKEN MEDICAL CO, LTD. 510(k) NO: K071694(TRADITIONAL)
ATTN: FUMIAK KANAI PHONE NO : 81 3 38188577
4-2-1 YUSHIMA, BUNKYO-KU SE DECISION MADE: 20-MAR-08
TOKYO, JAPAN 113-0034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANYANG HUALI K7 WHEELCHAIR
DANYANG HUAYI MEDICAL SUPPLY & EQU510(k) NO: K080207(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 12-MAR-08
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IM
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K073075(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 31-MAR-08
W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: MTA ROOT CANAL SEALER
DENTSPLY INTERNTIONAL 510(k) NO: K080203(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 26-MAR-08
SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
DENTSPLY INTL. 510(k) NO: K072730(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 WEST PHILADELPHIA STREET SE DECISION MADE: 27-MAR-08
SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K080352(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-977-3359
325 PARAMOUNT DR. SE DECISION MADE: 12-MAR-08
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-
DEVICE PARTNERS INTERNATIONAL 510(k) NO: K073260(ABBREVIATED)
ATTN: MONICA E DOUGHERTY PHONE NO : 210-957-2083
4305 ENTERPRISE DRIVE SE DECISION MADE: 13-MAR-08
SUITE E 510(k) SUMMARY AVAILABLE FROM FDA
WINSTON-SALEM, NC 27106
DEVICE: PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM
DIAGNOSTIC DEVICES INC. 510(k) NO: K073118(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 2 86358080
4F, 88, SEC. 1, KWANG FU ROAD SE DECISION MADE: 05-MAR-08
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME APOLIPOPROTEIN B ASSAY, MODEL DZXXX-X; B CALIBRATOR, MOD
DIAZYME LABORATORIES 510(k) NO: K073488(TRADITIONAL)
ATTN: CHARLES YU PHONE NO : 858-455-4761
12889 GREGG COURT SE DECISION MADE: 07-MAR-08
POWAY, CA 92064 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRAEGER ALCOTEST 6510
DRAGER SAFETY 510(k) NO: K063443(TRADITIONAL)
ATTN: EVE DAMIANO PHONE NO : 610-597-5499
333 ALPINE STREET SE DECISION MADE: 11-MAR-08
EMMAUS, PA 18049 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEP QUALITY
DYNADX CORPORATION 510(k) NO: K070855(TRADITIONAL)
ATTN: EJ SMITH PHONE NO : 410-451-0639
1676 VILLAGE GREEN STE. A SE DECISION MADE: 20-MAR-08
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LI
EDAN INSTRUMENTS, INC. 510(k) NO: K080087(TRADITIONAL)
ATTN: WILLIAM STERN PHONE NO : 914-376-5200
1 ODELL PLAZA SE DECISION MADE: 11-MAR-08
YONKERS, NY 10701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520
EIZO NANAO CORPORATION 510(k) NO: K080422(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 10-MAR-08
HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLOR LCD MONITOR, MODEL RADIFORCE RX211
EIZO NANAO CORPORATION 510(k) NO: K080457(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 817 627 42468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 20-MAR-08
HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRE, MODEL LP581
ELLEX MEDICAL PTY. LTD. 510(k) NO: K080423(SPECIAL)
ATTN: KEVIN HOWARD PHONE NO : 61 881 045200
82 GILBERT ST. SE DECISION MADE: 11-MAR-08
ADELAIDE, SOUTH AUSTRALIA, AUSTRAL510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HABIB HEXABLATE 10
EMCISION, LTD. 510(k) NO: K080717(TRADITIONAL)
ATTN: NAGY HABIB PHONE NO : 440 208 3832273
LIVER SURGERY, HAMMERSMITH SE DECISION MADE: 27-MAR-08
HOSPITAL CAMPUS, DU CANE RD. 510(k) SUMMARY AVAILABLE FROM FDA
LONDON, UK, UNITED KINGDOM W12 OHSTHIRD PARTY REVIEW
DEVICE: TENS/IF 14
EMSI 510(k) NO: K071869(TRADITIONAL)
ATTN: CHERITA JAMES PHONE NO : 703-562-9800
901 KING STREET SE DECISION MADE: 07-MAR-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
ALEXANDRIA, VA 22331
DEVICE: ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOUL
ENCORE MEDICAL, L.P. 510(k) NO: K080402(TRADITIONAL)
ATTN: TEFFANY HUTTO PHONE NO : 512-834-6255
9800 METRIC BLVD. SE DECISION MADE: 28-MAR-08
AUSTIN, TX 78758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORAC
ENDIUS, INC. 510(k) NO: K080258(TRADITIONAL)
ATTN: REGINA WAGNER PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 10-MAR-08
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO VIEWMATE SYSTEM
EP MEDSYSTEMS 510(k) NO: K073709(SPECIAL)
ATTN: LARRY PICCIANO PHONE NO : 856-753-8533
COOPER RUN EXECUTIVE PARK SE DECISION MADE: 11-MAR-08
575 ROUTE 73 N. BLDG. D 510(k) SUMMARY AVAILABLE FROM FDA
WEST BERLIN, NJ 08091
DEVICE: ANCHORAGE ACCESS KIT
EPITEK, INC. 510(k) NO: K073507(TRADITIONAL)
ATTN: WERNER HAMPL PHONE NO : 952-230-9886
4801 W. 81ST STREET SE DECISION MADE: 05-MAR-08
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, MN 55437
DEVICE: ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL -
ETHICON ENDO-SURGERY, INC. 510(k) NO: K073484(TRADITIONAL)
ATTN: RENEE L ROWE PHONE NO : 513-337-8243
4545 CREEK RD. SE DECISION MADE: 10-MAR-08
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL
EV3 INC. 510(k) NO: K072301(TRADITIONAL)
ATTN: DAVID WORRELL PHONE NO : 763-398-7344
4600 NATHAN LN. NORTH SE DECISION MADE: 18-MAR-08
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFU
FENWAL, INC. 510(k) NO: K073339(TRADITIONAL)
ATTN: TAMMY DAVIS PHONE NO : 847-550-7955
THREE CORPORATE DRIVE SE DECISION MADE: 03-MAR-08
LAKE ZURICH, IL 60047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRATORY HUMIDIFIER, MODEL MR850
FISHER & PAYKEL HEALTHCARE, LTD. 510(k) NO: K073706(TRADITIONAL)
ATTN: ADELE BINDON PHONE NO : 649 574 0100
15 MAURICE PAYKEL PLACE SE DECISION MADE: 31-MAR-08
EAST TAMAKI, NEW ZEALAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY
FOTONA D.D. 510(k) NO: K070355(TRADITIONAL)
ATTN: STOJAN TROST PHONE NO : 386 150 09100
STEGNE 7, SE DECISION MADE: 04-MAR-08
LJUBLJANA, SLOVENIA 1210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JNE IMPLANT SYSTEM
GC AMERICA, INC. 510(k) NO: K072425(ABBREVIATED)
ATTN: CARL JENKINS PHONE NO : 847-234-7500
1025 EVERETT ROAD, SUITE 100 SE DECISION MADE: 10-MAR-08
LAKE FOREST, IL 60045 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND
GE HEALTHCARE 510(k) NO: K061907(TRADITIONAL)
ATTN: JOEL C KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 27-MAR-08
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DASH 2500 PATIENT MONITOR
GE MEDICAL SYSTEMS INFORMATION TEC510(k) NO: K080157(TRADITIONAL)
ATTN: SHARON UNTZ PHONE NO : 414-362-2436
8200 WEST TOWER AVE. SE DECISION MADE: 24-MAR-08
MILWAUKEE, WI 53223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI-VUE SYSTEM
GENESIS DIGITAL IMAGING, INC. 510(k) NO: K073062(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 10-MAR-08
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINNITUS SOUND GENERATOR MODULE
GN RESOUND A/S 510(k) NO: K073636(TRADITIONAL)
ATTN: LARS HAGANDER PHONE NO : 454 575 1111
LAUTRUPBJERG 7 SE DECISION MADE: 13-MAR-08
BALLERUP, DENMARK DK-2750 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAFTYS BCP
GRAFTYS 510(k) NO: K073064(ABBREVIATED)
ATTN: ANTHONY LE NAOUR PHONE NO : 33 442 603000
415 RUE CHARLES NICOLAS LEDOUX SE DECISION MADE: 11-MAR-08
EIFFEL PARK BAT D 510(k) SUMMARY AVAILABLE FROM FDA
AIX EN PROVENCE, FRANCE 13854
DEVICE: LED.L, LED.M, LED.G, LED.B
GUILIN WOODPECKER MEDICAL INSTRUME510(k) NO: K080025(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 19-MAR-08
FLINTVILLE, TN 37335 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: VFLEX POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK,
GX CORPORATION SDN BHD 510(k) NO: K080066(TRADITIONAL)
ATTN: FOO KHON PU PHONE NO : 603 329 11600
LOT 6487, BATU 5 3/4, SEMENTA SE DECISION MADE: 05-MAR-08
JALAN KAPAR 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 42100
DEVICE: HENKE SASS WOLF OF AMERICA ARTHROSCOPE
HENKE SASS WOLF OF AMERICA, INC. 510(k) NO: K080560(TRADITIONAL)
ATTN: LYNETTE HOWARD PHONE NO : 908-788-4580
106 EAST 5TH AVENUE SE DECISION MADE: 18-MAR-08
MOUNT DORA, FL 32757 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIM
HILL LABORATORIES CO. 510(k) NO: K072256(TRADITIONAL)
ATTN: BRADY ALLER PHONE NO : 610-644-2867
3 N. BACTON HILL RD. SE DECISION MADE: 12-MAR-08
FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION BLOOD GLUCOSE MONITORING SYSTEM
HMD BIOMEDICAL LLC 510(k) NO: K072369(TRADITIONAL)
ATTN: MERRELL SHYE PHONE NO : 321-225-3620
8855 GRISSOM PARKWAY SE DECISION MADE: 21-MAR-08
TITUSVILLE, FL 32780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX 2.0 SOFTWARE FOR QDR X-RAY BONE DENSITOMETERS
HOLOGIC, INC. 510(k) NO: K072847(TRADITIONAL)
ATTN: BRYAN COWELL PHONE NO : 781-999-7300
35 CROSBY DR. SE DECISION MADE: 28-MAR-08
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABX PENTRA URINE CAL
HORIBA ABX 510(k) NO: K071779(ABBREVIATED)
ATTN: OLIVIER DUCAMP PHONE NO : 334 671 47392
PARC EUROMEDECINE SE DECISION MADE: 05-MAR-08
RUE DU CADUCEE, BP 7290 510(k) SUMMARY AVAILABLE FROM FDA
MONTPELLIER, FRANCE 34184
DEVICE: VARIAX DISTAL RADIUS TORX SCREWS
HOWMEDICA OSTEONICS CORP. 510(k) NO: K080667(SPECIAL)
ATTN: DANIELLE HILLMAN PHONE NO : 201-831-6365
325 CORPORATE DRIVE SE DECISION MADE: 19-MAR-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM
HYCOR BIOMEDICAL, INC. 510(k) NO: K080322(SPECIAL)
ATTN: P. NARAYAN NAYAK PHONE NO : 714-933-3145
7272 CHAPMAN AVE. SE DECISION MADE: 05-MAR-08
GARDEN GROVE, CA 92841 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISTAL HUMERAL PLATES WITH ANGULAR STABILITY
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K080184(TRADITIONAL)
ATTN: AL LIPPINOCOTT PHONE NO : 952-492-5858
3150 E. 200TH ST. SE DECISION MADE: 26-MAR-08
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPLUS DENTAL IMPLANTS (HA)
IMPLANT DIRECT LLC 510(k) NO: K073161(TRADITIONAL)
ATTN: THOMAS GOTTENBOS PHONE NO : 818-444-3317
27030 MALIBU HILLS RD. SE DECISION MADE: 07-MAR-08
CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUANTA LITE CCP3.1 IGG/IGA ELISA
INOVA DIAGNOSTICS, INC. 510(k) NO: K072944(TRADITIONAL)
ATTN: RUFUS BURLINGAME PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 05-MAR-08
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: SUB-TALAR LOK, MODEL 7-11 MM
INSTRATEK, INC. 510(k) NO: K080280(TRADITIONAL)
ATTN: JEFF SEAVEY PHONE NO : 281-890-8020
210 SPRING HILL DR. SE DECISION MADE: 14-MAR-08
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
THE WOODLANDS, TX 77386
DEVICE: MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM
INTUITIVE SURGICAL, INC. 510(k) NO: K080155(SPECIAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 06-MAR-08
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL S
INTUITIVE SURGICAL, INC. 510(k) NO: K080291(TRADITIONAL)
ATTN: KAREN UYESUGI PHONE NO : 408-523-8918
950 KIFER RD. SE DECISION MADE: 19-MAR-08
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISTAKON (NARAFILCON) A SOFT CONTACT LENS
JOHNSON & JOHNSON VISION CARE, INC510(k) NO: K073485(TRADITIONAL)
ATTN: ROSALIND B WILLIAMS PHONE NO : 904-443-3946
7500 CENTURION PKWY. SE DECISION MADE: 03-MAR-08
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
JACKSONVILLE, FL 32256
DEVICE: CAYMAN BUTTRESS PLATE SYSTEM
K2M, INC. 510(k) NO: K080302(TRADITIONAL)
ATTN: RICHARD WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 24-MAR-08
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
KENSEY NASH CORP. 510(k) NO: K073519(SPECIAL)
ATTN: CINDY VARUGHESE PHONE NO : 484-713-2100
735 PENNSYLVANIA DRIVE SE DECISION MADE: 28-MAR-08
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KFH ENERGY, MODEL: E1
KINGFISHER HEALTHCARE NV 510(k) NO: K073008(TRADITIONAL)
ATTN: NEIL R ARMSTRONG PHONE NO : 011 441 763222505
BUSINESS & TECHNOLOGY CENTER SE DECISION MADE: 11-MAR-08
BESSEMER DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
STEVENAGE, UNITED KINGDOM SG1 2DX
DEVICE: MODELS TENS 7000, EMS 7500 AND TWIN STIM
KOALATY PRODUCTS, INC. 510(k) NO: K080661(TRADITIONAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
845 ARONSON LAKE COURT SE DECISION MADE: 24-MAR-08
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NOCC HYDROPHILIC WOUND DRESSING
KYTOGENICS, INC 510(k) NO: K080010(TRADITIONAL)
ATTN: MARINA ZAZANIS PHONE NO : 973-410-0200
466 SOUTHERN BLVD. SE DECISION MADE: 14-MAR-08
ADAMS BUILDING, FIRST FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CHATHAM, NJ 07928
DEVICE: LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
LABORIE MEDICAL TECHNOLOGIES, CORP510(k) NO: K073552(TRADITIONAL)
ATTN: BARBARA MORNET PHONE NO : 802-857-1300
400 AVE D, STE 10 SE DECISION MADE: 05-MAR-08
WILLISTON, VT 05495 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANDREL GUIDEWIRES OR M-WIRE
LAKE REGION MEDICAL 510(k) NO: K080508(SPECIAL)
ATTN: KAREN MORTENSEN PHONE NO : 952-448-5111
340 LAKE HAZELTINE DRIVE SE DECISION MADE: 21-MAR-08
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINAL SPHERE SYSTEM
LIFE SPINE 510(k) NO: K073274(TRADITIONAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117
2401 W. HASSELL RD. SE DECISION MADE: 17-MAR-08
SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60169
DEVICE: LUMINEX LX 100/200 INSTRUMENT
LUMINEX CORP. 510(k) NO: K073506(TRADITIONAL)
ATTN: NANCY KRUNIC PHONE NO : 416 593 4323
439 UNIVERSITY AVENUE SUITE SE DECISION MADE: 07-MAR-08
2000 510(k) STATEMENT
TORONTO, CANADA M5G 1Y8
DEVICE: K-Y BRAND YOURS+MINE
MCNEIL-PPC, INC. 510(k) NO: K072421(TRADITIONAL)
ATTN: NADER FOTOUHI PHONE NO : 908-904-3730
199 GRANDVIEW ROAD SE DECISION MADE: 06-MAR-08
SKILLMAN, NJ 08558 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRIVE SOLSTICE OXYGEN CONCENTRATOR
MEDICAL DEPOT 510(k) NO: K080391(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 18-MAR-08
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COMPACT AUTO-SAFETY INJECTOR (CASI)
MEDICAL HOUSE (ASI) LIMITED 510(k) NO: K073476(TRADITIONAL)
ATTN: ROSE Y GUANG PHONE NO : 44 114 2619011
199, NEWHALL RD. SE DECISION MADE: 07-MAR-08
SHEFFIELD, UNITED KINGDOM S9 2QJ 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)
MEDICAL TECHNOLOGY SYSTEMS, INC. 510(k) NO: K063175(TRADITIONAL)
ATTN: ELLIS K NAM PHONE NO : 312-503-0073
6101 N. SHERIDAN RD. SE DECISION MADE: 14-MAR-08
SUITE 40D 510(k) STATEMENT
CHICAGO, IL 60660-6828
DEVICE: QPLAQUE MR
MEDIS MEDICAL IMAGING SYSTEMS, B.V510(k) NO: K073156(TRADITIONAL)
ATTN: J.I. HOLLANDER PHONE NO : 31 071 5223244
9 SCHUTTERSVELD SE DECISION MADE: 04-MAR-08
P.O. BOX 384 510(k) SUMMARY AVAILABLE FROM FDA
LEIDEN, NETHERLANDS 2316 XG
DEVICE: MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF
MEDLINE INDUSTRIES, INC. 510(k) NO: K071244(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847-643-4785
ONE MEDLINE PL. SE DECISION MADE: 05-MAR-08
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: MEDLINE GASTROSTOMY TUBE
MEDLINE INDUSTRIES, INC. 510(k) NO: K073718(ABBREVIATED)
ATTN: MATT CLAUSEN PHONE NO : 847-643-4785
ONE MEDLINE PL. SE DECISION MADE: 19-MAR-08
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: XPS 3000 SYSTEM
MEDTRONIC XOMED, INC. 510(k) NO: K073255(TRADITIONAL)
ATTN: DAVID GUZEK PHONE NO : 904-296-9600
6743 SOUTHPOINT DR. NORTH SE DECISION MADE: 24-MAR-08
JACKSONVILLE, FL 32216 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERRIES K-PHATE BONE GRAFT SUBSTITUTE
MERRIES INTERNATIONAL INC. 510(k) NO: K063157(TRADITIONAL)
ATTN: SOPHIA LEE PHONE NO : 886 289 117712
2F 3-1, BAU-HUNG RD. SE DECISION MADE: 10-MAR-08
SHIN-TIEN, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE LATEX EXAMINATION GLOVES - 18 MILS AT FINGER, BLUE C
METACURE SURGICAL GLOVES SDN BHD 510(k) NO: K072197(TRADITIONAL)
ATTN: AZMAN ISMAIL PHONE NO : 603 778 12829
NO. 1, JLN 203, OFF JALAN SE DECISION MADE: 12-MAR-08
TANDANG 510(k) STATEMENT
PETALING JAYA, MALAYSIA 46050
DEVICE: EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
MICROMEDICS, INC. 510(k) NO: K073401(TRADITIONAL)
ATTN: TOM LOPAC PHONE NO : 651-452-1977
1270 EAGAN INDUSTRIAL ROAD SE DECISION MADE: 14-MAR-08
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
EAGAN, MN 55121
DEVICE: MODIFICATION TO REBOUND HRD
MINNESOTA MEDICAL DEVELOPMENT, INC510(k) NO: K080393(SPECIAL)
ATTN: JULIE BULVER PHONE NO : 763-588-9839
4050 OLSON MEMORIAL HIGHWAY SE DECISION MADE: 13-MAR-08
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688
MOELLER MEDICAL GMBH & CO. KG 510(k) NO: K072793(SPECIAL)
ATTN: BILL KELLEY PHONE NO : 949-292-8477
23832 VIA MONTE SE DECISION MADE: 04-MAR-08
COTO DE CAZA, CA 92679-4001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KANTERON DICOM STATION (KDS), MODEL 3.0
MONICA VEYTIA 510(k) NO: K073176(TRADITIONAL)
ATTN: MONICA VEYTIA PHONE NO : 305-283-1517
7195 SW 101 ST SE DECISION MADE: 19-MAR-08
MIAMI, FL 33156 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED CURING LIGHT
MONITEX INDUSTRIAL CO., LTD. 510(k) NO: K080035(TRADITIONAL)
ATTN: SHU-LUNG WANG PHONE NO : 886 229 993869
6F, 70 SEC. 1 GUANG-FU ROAD SE DECISION MADE: 03-MAR-08
SAN-CHUNG CITY, CHINA (TAIWAN) 241510(k) STATEMENT
DEVICE: MINITAPE EXTRA URETHRAL SLING
MPATHY MEDICAL DEVICES, LTD. 510(k) NO: K073647(SPECIAL)
ATTN: LOUIS J MAZZARESE PHONE NO : 203-318-8270
24 BARBERRY LANE SE DECISION MADE: 03-MAR-08
MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MCT-DIABETES
MYCARE TEAM, INC. 510(k) NO: K073699(TRADITIONAL)
ATTN: DIANE MANDELL HORWITZ PHONE NO : 703-242-0027
PO BOX 2552 SE DECISION MADE: 26-MAR-08
FAIRFAX, VA 22031 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ND LOW SPEED AIRMOTOR AND HANDPIECE, HIGHSPEED AIRTURBINE HANDP
NAKAMURA MAGNIFIER CO., LTD. 510(k) NO: K073652(TRADITIONAL)
ATTN: CHARLIE ITO PHONE NO : 949-474-0176
17972 SKY PARK CIRCLE SE DECISION MADE: 20-MAR-08
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
IRVINE, CA 92614
DEVICE: PLICATOR GSX SUTURING SYSTEM, PLICATOR GSX, PLICATOR INSTRUMENT,
NDO SURGICAL, INC. 510(k) NO: K073671(TRADITIONAL)
ATTN: JOHN J VOZELLA PHONE NO : 508-337-8881
125 HIGH ST., SE DECISION MADE: 26-MAR-08
SUITE 7 510(k) SUMMARY AVAILABLE FROM FDA
MANSFIELD, MA 02048
DEVICE: SAVANNAH LUMBAR PERCUTANEOUS STABILIZATION SYSTEM
NEUROSPINE INNOVATIONS AND SOLUTIO510(k) NO: K072116(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999
13540 GUILD AVE. SE DECISION MADE: 20-MAR-08
APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K080540(TRADITIONAL)
ATTN: TIAN YANFANG PHONE NO : 86 24 83660649
NO.3-11, WENHUA ROAD SE DECISION MADE: 13-MAR-08
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004 THIRD PARTY REVIEW
DEVICE: E-VAC
NEW LEAF MEDICAL, INC. 510(k) NO: K073455(SPECIAL)
ATTN: RICHARD T NOCK PHONE NO : 440-748-7000
11476 HAWKE RD SE DECISION MADE: 25-MAR-08
SUITE #C 510(k) STATEMENT
COLUMBIA STATION, OH 44028
DEVICE: PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION
NIHON KOHDEN AMERICA, INC. 510(k) NO: K073550(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 28-MAR-08
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
NOVAMIN TECHNOLOGY, INC. 510(k) NO: K080228(TRADITIONAL)
ATTN: ROBERT G ROTHFRITZ PHONE NO : 386-418-1551
13859 PROGRESS BLVD.,#600 SE DECISION MADE: 27-MAR-08
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCIN
NOVARTIS NUTRITION CORP. 510(k) NO: K080340(SPECIAL)
ATTN: THOMAS A DOLD PHONE NO : 952-848-6480
12500 WHITEWATER DRIVE SE DECISION MADE: 05-MAR-08
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPINOUS PROCESS PLATE SYSTEM
NUVASIVE, INC. 510(k) NO: K073278(TRADITIONAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-909-1868
4545 TOWNE CENTRE COURT SE DECISION MADE: 28-MAR-08
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DURETTE IMPLANT
OCULO PLASTIK, INC. 510(k) NO: K073293(TRADITIONAL)
ATTN: JEAN-FRANCOIS DURETTE PHONE NO : 514 381 3292
200 SAUVE WEST SE DECISION MADE: 19-MAR-08
MONTREAL, QC, CANADA H3L 1Y9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMALL INTESTINAL VIDEOSCOPE SYSTEM
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K071254(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 25-MAR-08
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: EVIS EXERA II 180 SYSTEM
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K072957(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 18-MAR-08
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: TRAUMACAD VERSION 2.0
ORTHOCRAT, LTD. 510(k) NO: K073714(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVENUE SE DECISION MADE: 19-MAR-08
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODULAR FOOT SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K073624(TRADITIONAL)
ATTN: DEREK LEWIS PHONE NO : 330-869-9562
1815 W. MARKET ST. SE DECISION MADE: 20-MAR-08
SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA
AKRON, OH 44313
DEVICE: DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HE
OSPOL AB 510(k) NO: K070184(TRADITIONAL)
ATTN: LENNART CARLSSON PHONE NO : 46 40 6037610
JORGEN KOCKSGATAN 9 SE DECISION MADE: 24-MAR-08
MALMO, SWEDEN SE-211 20 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: US/SS/GS SYSTEM
OSSTEM IMPLANT CO LTD 510(k) NO: K073247(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 215-736-2990
ONE BEN FAIRLESS DR SE DECISION MADE: 07-MAR-08
FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HU II / HS II FIXTURE SYSTEM
OSSTEM IMPLANT CO.,LTD 510(k) NO: K080387(SPECIAL)
ATTN: MIN JOO KIM PHONE NO : 215-736-2990
1 BEN FAIRLESS DR. SE DECISION MADE: 07-MAR-08
FAIRLESS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PLEXUR M
OSTEOTECH, INC. 510(k) NO: K073405(TRADITIONAL)
ATTN: CHRISTOPHER TALBOT PHONE NO : 732-542-2800
51 JAMES WAY SE DECISION MADE: 03-MAR-08
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300
PALADIN BIOMEDICAL CORPORATION 510(k) NO: K073363(TRADITIONAL)
ATTN: ROBERT BICKFORD PHONE NO : 781-964-2237
506 BOSTON POST ROAD SE DECISION MADE: 20-MAR-08
WESTON, MA 02493 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PALOMAR LUX1540 HANDPIECE
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K073583(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414
82 CAMBRIDGE ST. SE DECISION MADE: 26-MAR-08
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRJ EXTENDED
PARAMED SRL 510(k) NO: K080098(TRADITIONAL)
ATTN: MICHAEL A DOUGLAS PHONE NO : 978-975-7530
39 HIGH STREET SE DECISION MADE: 10-MAR-08
NORTH ANDOVER, MA 01845 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SECURE
PARKELL, INC. 510(k) NO: K073698(TRADITIONAL)
ATTN: DANIEL R SCHECHTER PHONE NO : 631-249-1134
300 EXECUTIVE DR. SE DECISION MADE: 19-MAR-08
EDGEWOOD, NY 11717 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JET PORT PLUS HP CATHETER SYSTEM
PFM MEDICAL, INC 510(k) NO: K072481(TRADITIONAL)
ATTN: SALVADORE PALOMARES PHONE NO : 760-758-8749
2605 TEMPLE HEIGHTS DRIVE SE DECISION MADE: 07-MAR-08
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
OCEANSIDE, CA 92056
DEVICE: STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0
PHILIPS MEDICAL SYSTEMS 510(k) NO: K080461(SPECIAL)
ATTN: ZETY BILLARD PHONE NO : 978-659-3603
3000 MINUTEMAN RD. SE DECISION MADE: 13-MAR-08
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 A
PHILIPS MEDICAL SYSTEMS 510(k) NO: K080495(SPECIAL)
ATTN: MARY KRUITWAGEN PHONE NO : 978-659-4932
3000 MINUTEMAN RD. SE DECISION MADE: 24-MAR-08
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HFO SHOULDER COIL
PHILIPS MEDICAL SYSTEMS MR FINLAND510(k) NO: K080120(TRADITIONAL)
ATTN: CATHERINE CONNELL PHONE NO : 440-483-5581
595 MINER ROAD SE DECISION MADE: 10-MAR-08
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HD7 DIAGNOSTIC ULTRASOUND SYSTEM
PHILLIPS MEDICAL SYSTEMS 510(k) NO: K080548(TRADITIONAL)
ATTN: NANCY BURKE PHONE NO : 425-487-7371
22100 BOTHELL EVERETT HIGHWAY SE DECISION MADE: 27-MAR-08
BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: XTRAC ULTRA 2, MODEL AL10000
PHOTO MEDEX, INC. 510(k) NO: K073659(TRADITIONAL)
ATTN: JEFF LEVATTER PHONE NO : 760-602-3300
2375 CAMINO VIDA ROBLE, SE DECISION MADE: 05-MAR-08
SUITE B 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92011
DEVICE: OMNILUX NEW-U
PHOTO THERAPEUTICS, INC. 510(k) NO: K072459(TRADITIONAL)
ATTN: SUE DARCY PHONE NO : 780-607-0488
2720 LOKER AVENUE WEST SE DECISION MADE: 03-MAR-08
CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER LOWTOP SPINAL ROD SYSTEM
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K080504(SPECIAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 20-MAR-08
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
PIONEER SURGICAL TECHNOLOGY 510(k) NO: K080518(SPECIAL)
ATTN: JONATHAN M GILBERT PHONE NO : 906-226-4812
375 RIVER PARK CIRCLE SE DECISION MADE: 20-MAR-08
MARQUETTE, MI 49855-0627 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SWIFT LT
RESMED LTD. 510(k) NO: K073638(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 20-MAR-08
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RESPIRONICS GOLOX
RESPIRONICS, INC. 510(k) NO: K072723(TRADITIONAL)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1740 GOLDEN MILE HIGHWAY SE DECISION MADE: 20-MAR-08
MONROEVILLE, PA 15146 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PORTRAIT PSR, MODEL 745915
RHYTEC INCORPORATED 510(k) NO: K073111(TRADITIONAL)
ATTN: ROBERT ZOLETTI PHONE NO : 781-419-9482
130 TURNER STREET SE DECISION MADE: 27-MAR-08
BUILDING 2 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02453
DEVICE: PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIE
RJ MEDICAL, INC. 510(k) NO: K073544(TRADITIONAL)
ATTN: JIM INNES PHONE NO : 916-941-6913
4921 ROBERT J. MATHEWS PKWY SE DECISION MADE: 05-MAR-08
#2 510(k) SUMMARY AVAILABLE FROM FDA
EL DORADO HILLS, CA 95762
DEVICE: COBAS LITHIUM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K063684(TRADITIONAL)
ATTN: THERESA AMBROSE BUSH PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 21-MAR-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE-CREACTIVE PROTEIN (LATEX)
ROCHE DIAGNOSTICS CORP. 510(k) NO: K073277(SPECIAL)
ATTN: KERWIN L KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE RD. SE DECISION MADE: 06-MAR-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTR
ROCHE DIAGNOSTICS CORP. 510(k) NO: K080183(ABBREVIATED)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. BX 50416 SE DECISION MADE: 25-MAR-08
INDIANAPOLIS, IN 46250-0416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SALVIN DENTAL SPECIALTIES, INC., FIXATION SCREW
SALVIN DENTAL SPECIALTIES, INC. 510(k) NO: K073342(TRADITIONAL)
ATTN: ROBERT SALVIN PHONE NO : 704-442-5400
3450 LATROBE DR. SE DECISION MADE: 26-MAR-08
CHARLOTTE, NC 28211 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3
SANARUS MEDICAL, INC. 510(k) NO: K080171(TRADITIONAL)
ATTN: LISA HENRY PHONE NO : 925-460-5732
4696 WILLOW RD. SE DECISION MADE: 06-MAR-08
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
SENORX, INC. 510(k) NO: K080698(SPECIAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800
11 COLUMBIA SE DECISION MADE: 31-MAR-08
ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER-FREE, BLACK NITRILE EXAMINATION GLOVES
SGMP CO., LTD. 510(k) NO: K072400(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 27-MAR-08
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY
SGMP CO., LTD. 510(k) NO: K072403(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 27-MAR-08
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHE
SGMP CO., LTD. 510(k) NO: K072406(TRADITIONAL)
ATTN: JANNA P TUCKER PHONE NO : 775-342-2612
198 AVENUE DE LA D'EMERALD SE DECISION MADE: 21-MAR-08
SPARKS, NV 89434 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEE
SHANDONG QAIOPAI GROUP COMPANY, LT510(k) NO: K073705(TRADITIONAL)
ATTN: PHONE NO :
NO 13 QUINGHE ROAD SE DECISION MADE: 24-MAR-08
GAOQING, SHANGDONG, CHINA 518054 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: JIERUI SYRINGES AND NEEDLES
SHANDONG WEIGAO GROUP MEDICAL POLY510(k) NO: K072739(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 021 642 64467
SUITE 8D, NO.19, LANE 999 SE DECISION MADE: 21-MAR-08
ZHONGSHAN NO.2 ROAD(S) 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: M5 DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K080640(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 21-MAR-08
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BONE FIXATION WIRE (KIRSCHNER WIRE)
SIGNAL MEDICAL CORP. 510(k) NO: K073674(TRADITIONAL)
ATTN: LOUIS A SERAFIN PHONE NO : 810-364-7070
400 PYRAMID DR. SE DECISION MADE: 24-MAR-08
MARYSVILLE, MI 48040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBA MINI
SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K080349(SPECIAL)
ATTN: ALAN ALEXANDER PHONE NO : 763-287-3830
4050 OLSON MEMORIAL HWY SE DECISION MADE: 10-MAR-08
SUITE 350 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55422
DEVICE: SBI SR MTP TOE IMPLANT
SMALL BONE INNOVATIONS INC. 510(k) NO: K073635(TRADITIONAL)
ATTN: JEFFREY ZIGLER PHONE NO : 202-552-5800
1331 H STREET NW, 12TH FL SE DECISION MADE: 19-MAR-08
WASHINGTON, DC 20005 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
SMITH & NEPHEW, INC. 510(k) NO: K072212(SPECIAL)
ATTN: DAVID HENLEY PHONE NO : 901-399-6487
1450 BROOKS RD. SE DECISION MADE: 07-MAR-08
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWINFIX PK FP SUTURE ANCHOR
SMITH & NEPHEW, INC. 510(k) NO: K073509(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036
150 MINUTEMAN RD. SE DECISION MADE: 04-MAR-08
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION
SMITHS MEDICAL MD, INC. 510(k) NO: K072144(TRADITIONAL)
ATTN: PHIL NEURURER PHONE NO : 651-628-7592
1265 GREY FOX RD. SE DECISION MADE: 07-MAR-08
ARDEN HILLS, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PREVADH MESH
SOFRADIM PRODUCTION 510(k) NO: K073287(TRADITIONAL)
ATTN: SHARON ALEXANDER PHONE NO : 203-492-6060
60 MIDDLETOWN AVENUE SE DECISION MADE: 13-MAR-08
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODE
SOMATEX MEDICAL TECHNOLOGIES GMBH 510(k) NO: K073095(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 617-547-0628
1480 CAMBRIDGE STREET SE DECISION MADE: 19-MAR-08
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSS SYSTEM
SPINAL USA 510(k) NO: K073240(SPECIAL)
ATTN: JEFFREY JOHNSON PHONE NO : 601-420-4244
644 LAKELAND EAST DR., STE. A SE DECISION MADE: 20-MAR-08
FLOWOOD, MS 39232 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUREX PLAY MASSAGE GEL LUBRICANT
SSL AMERICAS, INC. 510(k) NO: K063385(TRADITIONAL)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2152
3585 ENGINEERING DR. SE DECISION MADE: 10-MAR-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
NORCROSS, GA 30092
DEVICE: ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K072864(TRADITIONAL)
ATTN: COLLEEN CANAN PHONE NO : 818-493-2960
15900 VALLEY VIEW CT. SE DECISION MADE: 13-MAR-08
SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
STAAR SURGICAL CO. 510(k) NO: K073586(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 626-303-7902
1911 WALKER AVE. SE DECISION MADE: 13-MAR-08
MONROVIA, CA 91016 510(k) STATEMENT
DEVICE: MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
STAAR SURGICAL CO. 510(k) NO: K073591(TRADITIONAL)
ATTN: DIANA SMITH PHONE NO : 626-303-7902
1911 WALKER AVE. SE DECISION MADE: 13-MAR-08
MONROVIA, CA 91016 510(k) STATEMENT
DEVICE: MUSCLE PAIN DEVICE (MPD)
STEVENS PROOF OF CONCEPT, INC. 510(k) NO: K073361(TRADITIONAL)
ATTN: JECKIN D SHAH PHONE NO : 203-921-0352
68 SOUTHFIELD AVE. STE 100-2 SE DECISION MADE: 18-MAR-08
STAMFORD LANDING 510(k) STATEMENT
STAMFORD, CT 06902 THIRD PARTY REVIEW
DEVICE: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS
STRAUMANN USA 510(k) NO: K080286(SPECIAL)
ATTN: ELAINE ALAN PHONE NO : 978-747-2513
60 MINUTEMAN ROAD SE DECISION MADE: 07-MAR-08
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVS PL PEEK SPACERS, MODELS 48351 AND 48353
STRYKER CORP. 510(k) NO: K080758(SPECIAL)
ATTN: VIKKI M O'CONNOR PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 27-MAR-08
ALLENDALE, NJ 07645 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER ANTIMIC CATHETER
STRYKER INSTRUMENTS, INSTRUMENTS D510(k) NO: K072702(TRADITIONAL)
ATTN: JULIE PRYOR PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 19-MAR-08
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX
STRYKER SPINE 510(k) NO: K073470(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 06-MAR-08
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INREACH SYSTEM
SUPERDIMENSION, LTD. 510(k) NO: K080271(TRADITIONAL)
ATTN: JONATHAN KOVACH PHONE NO : 763-210-4015
161 CHESHIRE LANE NORTH, SE DECISION MADE: 31-MAR-08
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55441-5433
DEVICE: QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANON
SURGICAL SPECIALTIES CORP. 510(k) NO: K080680(SPECIAL)
ATTN: TRUDY D ESTRIDGE PHONE NO : 703-796-8927
13921 PARK CENTER RD. SE DECISION MADE: 21-MAR-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
HERNDON, VA 20171
DEVICE: SUTTER ELECTROSURGICAL CABLES
SUTTER MEDIZINTECHNIK GMBH 510(k) NO: K073450(TRADITIONAL)
ATTN: THOMAS A BOONE PHONE NO : 505-977-9497
353 LOMA LARGA ROAD SE DECISION MADE: 17-MAR-08
CORRALES, NM 87048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR
SYNERGEYES, INC. 510(k) NO: K080193(TRADITIONAL)
ATTN: RICHARD E LIPPMAN PHONE NO : 240-683-3738
15825 SHADY GROVE ROAD SE DECISION MADE: 05-MAR-08
SUITE 30 510(k) STATEMENT
ROCKVILLE, MD 20850
DEVICE: QUANTITATIVE NEUROQ 3.0
SYNTERMED, INC. 510(k) NO: K072307(TRADITIONAL)
ATTN: KENNETH TRAIN PHONE NO : 714-281-1256
245 OWENS DR. SE DECISION MADE: 14-MAR-08
ANAHEIM, CA 92808 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
SYNTHES (USA) 510(k) NO: K080109(TRADITIONAL)
ATTN: JILL R SHERMAN PHONE NO : 610-719-6538
1301 GOSHEN PKWY SE DECISION MADE: 20-MAR-08
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEVER CHEK MODEL TD-4232 BLOOD GLUCOSE MONITORING SYSTEM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K073119(TRADITIONAL)
ATTN: ERICA LI PHONE NO : 886 2 66358080
4F, 88, SEC.1, KWANG FU ROAD SE DECISION MADE: 03-MAR-08
SAN CHUNG, TAIPEI, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APX21
TECHDENT TECHNOLOGIES, LTD. 510(k) NO: K073185(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 4 9947880
MIZPE AVIV, INDUSTRIAL PARK 13 SE DECISION MADE: 06-MAR-08
M.P. MISGAV, ISRAEL 20187 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPIOX CIRCUIT CONNECTORS
TERUMO CORP. 510(k) NO: K073474(TRADITIONAL)
ATTN: GARRY COURTNEY PHONE NO : 800-283-7866
125 BLUE BALL RD. SE DECISION MADE: 05-MAR-08
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING S
TERUMO MEDICAL CORP. 510(k) NO: K080415(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7213
950 ELKTON BLVD. SE DECISION MADE: 07-MAR-08
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUNTHROUGH NS EXTENSION WIRE
TERUMO MEDICAL CORP. 510(k) NO: K080563(SPECIAL)
ATTN: MARK UNTERREINER PHONE NO : 410-392-7231
950 ELKTON BLVD. SE DECISION MADE: 20-MAR-08
ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INPLEX CF MOLECULAR TEST
THIRD WAVE TECHNOLOGIES, INC. 510(k) NO: K063787(TRADITIONAL)
ATTN: ANDREW A LUKOWIAK PHONE NO : 608-273-8933
502 SOUTH ROSA RD. SE DECISION MADE: 13-MAR-08
MADISON, WI 53719-1256 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMECHECK MULTIPLE DRUG CUP TEST
TIANJIN NEW BAY BIORESEARCH CO., L510(k) NO: K071489(TRADITIONAL)
ATTN: ARMANDO A TORRESCANO PHONE NO : 760-685-3658
3108 AVENIDA OLMEDA SE DECISION MADE: 28-MAR-08
CARLSBAD, CA 92009 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K080211(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 14-MAR-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: TRANS1 FACET SCREW
TRANS1 INCORPORATED 510(k) NO: K073515(TRADITIONAL)
ATTN: WILLIAM JACKSON PHONE NO : 910-332-1727
411 LANDMARK DR. SE DECISION MADE: 11-MAR-08
WILMINGTON, NC 28412 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SENSITITRE 18-24 SUSCEPTIBILITY PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K073558(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 13-MAR-08
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K073653(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 216-351-8735
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 20-MAR-08
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEM
TYSON BIORESEARCH, INC. 510(k) NO: K072441(TRADITIONAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 375 85988
5F, #22, KE E. ROAD, III SE DECISION MADE: 25-MAR-08
SCIENCE-BASED INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
CHU-NAN, CHINA (TAIWAN) 350
DEVICE: CLARIVEIN CATHETER
VASCULAR INSIGHTS LLC 510(k) NO: K071468(ABBREVIATED)
ATTN: JOHN P MARANO PHONE NO : 203-245-9120
395 BOSTON POST ROAD SE DECISION MADE: 20-MAR-08
MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARI-LASE ENDOVENOUS LASER CONSOLE, MODEL 7542
VASCULAR SOLUTIONS, INC. 510(k) NO: K080104(TRADITIONAL)
ATTN: JAMES CHAPMAN PHONE NO : 763-656-4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 26-MAR-08
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENOWAVE MODELS VW5-6, VW5-10, VW5-20 AND VW5-30
VENOWAVE, INC. 510(k) NO: K073028(TRADITIONAL)
ATTN: JOHN SARINGER PHONE NO : 905 888 1888
13231 KENNEDY ROAD SE DECISION MADE: 07-MAR-08
STOUFFVILLE, ONTARIO, CANADA L4A 7510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTLAB NASAL CO2 SAMPLING/O2 DELIVERY CANNULA
VENTLAB CORP. 510(k) NO: K063813(TRADITIONAL)
ATTN: JAMES A COCHIE PHONE NO : 336-753-5000
155 BOYCE DRIVE SE DECISION MADE: 26-MAR-08
MOCKSVILLE, NC 27028 510(k) STATEMENT
DEVICE: VERTEBRON VBR SYSTEM
VERTEBRON, INC. 510(k) NO: K073502(TRADITIONAL)
ATTN: LUIS NESPRIDO PHONE NO : 203-380-9340
80 HATHAWAY DRIVE SE DECISION MADE: 24-MAR-08
STRATFORD, CT 06615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIRTUAL PORTS ENDOCLEAR SYSTEM
VIRTUAL PORTS LTD 510(k) NO: K080051(TRADITIONAL)
ATTN: YORAM LEVY PHONE NO : 972 4 6388837
31 HAAVODA STREET SE DECISION MADE: 21-MAR-08
BINYAMINA, ISRAEL 30500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VS-VISIONSENSE STEREOSCOPIC VISION SYSTEM
VISIONSENSE, LTD. 510(k) NO: K073279(SPECIAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5735
555 13TH STREET, NW SE DECISION MADE: 05-MAR-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOYALA FULL FACE MASK GEL VENTED
WEINMANN GERATE FUR MEDIZIN GMBH +510(k) NO: K073673(SPECIAL)
ATTN: RALF EGENOLF PHONE NO : 011 494 054802370
KRONSAALSWEG 40 SE DECISION MADE: 28-MAR-08
HAMBURG, GERMANY 22525 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK CLECT VENA CAVA FILTER, GUNTHER TULIP VENA CAVA FILTER RETR
WILLIAM COOK EUROPE APS 510(k) NO: K073374(TRADITIONAL)
ATTN: MOLLY BUSENBARK PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 07-MAR-08
P.O. BOX 489 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, IN 47402-0489
DEVICE: OCCLUFAST CAD
ZHERMACK S.P.A. 510(k) NO: K080130(SPECIAL)
ATTN: GERALD W SHIPPS PHONE NO : 541-389-5935
19379 BLUE LAKE LOOP SE DECISION MADE: 14-MAR-08
BEND, OR 97702 510(k) STATEMENT
DEVICE: ZIEHM VISION
ZIEHM IMAGING, INC. 510(k) NO: K073346(TRADITIONAL)
ATTN: RICHARD WESTRICH PHONE NO : 951-781-2020
4181 LATHAM ST. SE DECISION MADE: 21-MAR-08
RIVERSIDE, CA 92501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER POROLOCK MIS STEM
ZIMMER GMBH 510(k) NO: K071723(TRADITIONAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907
P.O. BOX 708 SE DECISION MADE: 07-MAR-08
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
ZIMMER GMBH 510(k) NO: K073567(TRADITIONAL)
ATTN: PATRICIA JENKS PHONE NO : 574-371-8354
P.O. BOX 708 SE DECISION MADE: 13-MAR-08
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
ZIMMER, INC. 510(k) NO: K073286(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 07-MAR-08
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOPULSE RESUSCITATION SYSTEM, MODEL 100
ZOLL CIRCULATION 510(k) NO: K072527(TRADITIONAL)
ATTN: MARK PERKINS PHONE NO : 408-541-2140
249 HUMBOLDT COURT SE DECISION MADE: 19-MAR-08
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 234
TOTAL WITH SUMMARIES 211
TOTAL WITH STATEMENTS 23
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