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Medical Devices
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February 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-FEB-2008 THROUGH 28-FEB-2008
DEVICE: 3M ESPE ADULT CROWN
3M COMPANY 510(k) NO: K072733(TRADITIONAL)
ATTN: SCOTT ERICKSON PHONE NO : 651-736-9883
EM CENTER, BLDG. 260-2A-11 SE DECISION MADE: 15-FEB-08
ST PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAVA FRAME, LAVA FRAME SHADE
3M ESPE AG DENTAL PRODUCTS 510(k) NO: K072055(TRADITIONAL)
ATTN: DESI W SOEGIARTO PHONE NO : 011 498 1527001169
ESPE PLATZ SE DECISION MADE: 26-FEB-08
SEEFELD, BAVARIA, GERMANY D-82229 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRANSBOND SUPREME ADHESIVE
3M UNITEK 510(k) NO: K073697(TRADITIONAL)
ATTN: L. MARLYN SCHEFF PHONE NO : 626-574-4496
2724 SOUTH PECK RD. SE DECISION MADE: 15-FEB-08
MONROVIA, CA 91016 510(k) STATEMENT
DEVICE: FOX 1-980, FOX Q-1064, FOX-Q-810
A.R.C. LASER GMBH 510(k) NO: K073322(TRADITIONAL)
ATTN: KIRSTEN H PAULSON PHONE NO : 301-795-2639
3202 TOWER OAKS BLVD SE DECISION MADE: 22-FEB-08
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: ACCIN PEDICLE SCREW SYSTEM
ACCELERATED INNOVATION, LLC 510(k) NO: K073531(TRADITIONAL)
ATTN: MICHAEL KVITNITSKY PHONE NO : 973-777-8832
1033 US HIGHWAY 46 EAST SE DECISION MADE: 04-FEB-08
SUITE A204 510(k) SUMMARY AVAILABLE FROM FDA
CLIFTON, NJ 07013
DEVICE: ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
ACE SURGICAL SUPPLY CO., INC. 510(k) NO: K080074(SPECIAL)
ATTN: J. EDWARD CARCHIDI PHONE NO : 508-588-3100
1034 PEARL ST. SE DECISION MADE: 14-FEB-08
BROCKTON, MA 02301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHA INFUSION PUMP, MODEL A200, A450
ADVANCED INFUSION, INC. 510(k) NO: K071532(TRADITIONAL)
ATTN: JAMES CHRISTENSEN PHONE NO : 909-394-4916
466 WEST ARROW HWY., UNIT H SE DECISION MADE: 19-FEB-08
SAN DIMAS, CA 91773 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REUSABLE HEADREST WITH NASAL SEAL
AEIOMED, INC. 510(k) NO: K072993(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 08-FEB-08
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORTHOPILOT 2 TOTAL HIP ARTHROPLASTY (THA) VERSION 3.0
AESCULAP IMPLANT SYSTEMS, INC. 510(k) NO: K072899(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 06-FEB-08
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMERTEST
AMERICAN DIAGNOSTICA, INC. 510(k) NO: K080069(TRADITIONAL)
ATTN: LEIGH AYRES PHONE NO : 203-602-7777
500 WEST AVENUE SE DECISION MADE: 13-FEB-08
STAMFORD, CT 06902 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XVIEWNET
AMERICAN RADIOLOGIST NETWORK, INC.510(k) NO: K080290(TRADITIONAL)
ATTN: IAN GORDON PHONE NO :
1705 S. CAPITAL OF TEXAS HWY. SE DECISION MADE: 22-FEB-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746 THIRD PARTY REVIEW
DEVICE: GRIND GUARD
ARCHTEK, INC. 510(k) NO: K073446(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 512-327-9997
1705 SOUTH CAPITOL OF TEXAS HW SE DECISION MADE: 08-FEB-08
AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MENISCAL CINCH
ARTHREX, INC. 510(k) NO: K073149(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-598-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 11-FEB-08
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHREX COMPRESSION STAPLE
ARTHREX, INC. 510(k) NO: K080111(TRADITIONAL)
ATTN: SALLY FOUST PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 13-FEB-08
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00,
ARTHROCARE CORP. 510(k) NO: K080282(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 15-FEB-08
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT FOR BIOHORIZON IMPLANTS, ATLANTIS GEMINI ABUTM
ATLANTIS COMPONENTS, INC. 510(k) NO: K073258(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 14-FEB-08
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFINION ACR AND ACR CONTROL
AXIS-SHIELD POC AS 510(k) NO: K072409(TRADITIONAL)
ATTN: JORUNN GREVIE LOLLAND PHONE NO : 47 22 042000
MARSTRANDGATA 6 SE DECISION MADE: 12-FEB-08
PO BOX 6863 510(k) SUMMARY AVAILABLE FROM FDA
RODELOKKA, OSLO, NORWAY N-0504
DEVICE: CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL
BARCOVIEW, MEDICAL IMAGING SYSTEMS510(k) NO: K073007(TRADITIONAL)
ATTN: NEIL PHILLIPS PHONE NO : 32 562 33211
35 PRESIDENT KENNEDYPARK SE DECISION MADE: 14-FEB-08
KORTRIJK, BELGIUM B-8500 510(k) STATEMENT
DEVICE: BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOL
BAUSCH & LOMB, INC. 510(k) NO: K073184(ABBREVIATED)
ATTN: DEBRA KETCHUM PHONE NO : 585-338-8638
1400 NORTH GOODMAN ST. SE DECISION MADE: 21-FEB-08
ROCHESTER, NY 14609 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
BEDFONT SCIENTIFIC LTD. 510(k) NO: K070259(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 410-451-0639
PO BOX 4341 SE DECISION MADE: 21-FEB-08
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROSTIM 1000/2000
BIO PROTECH, INC. 510(k) NO: K073438(TRADITIONAL)
ATTN: E.J. SMITH PHONE NO : 888-729-9674
1676 VILLAGE GREEN SUITE A SE DECISION MADE: 07-FEB-08
CROFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM
BIO-LOGIC SYSTEMS CORP. 510(k) NO: K073626(SPECIAL)
ATTN: NICOHL WILDING PHONE NO : 847-949-5200
ONE BIOLOGIC PLAZA SE DECISION MADE: 05-FEB-08
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOHORIZONS INTERNAL IMPLANT SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K073268(TRADITIONAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880
2300 RIVERCHASE CENTER SE DECISION MADE: 08-FEB-08
BIRMINGHAM, AL 35244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
BIOHORIZONS IMPLANT SYSTEMS, INC. 510(k) NO: K073282(TRADITIONAL)
ATTN: WINSTON GREER PHONE NO : 205-967-7880
2300 RIVERCHASE CENTER SE DECISION MADE: 15-FEB-08
BIRMINGHAM, AL 35244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WATERLASE AND WATERLASE MD
BIOLASE TECHNOLOGY, INC. 510(k) NO: K071363(TRADITIONAL)
ATTN: IOANA RIZOU PHONE NO : 949-226-8144
4 CROMWELL SE DECISION MADE: 12-FEB-08
IRVINE, CA 92618-1816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15W CERALAS D 1470NM DIODE LASER
BIOLITEC, INC. 510(k) NO: K073063(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 27-FEB-08
WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
BIOMERIEUX, INC. 510(k) NO: K080107(TRADITIONAL)
ATTN: NANCY WEAVER PHONE NO : 314-731-8695
595 ANGLUM RD. SE DECISION MADE: 28-FEB-08
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOMERIX SURGICAL MESH, MODEL: RCR-01
BIOMERIX CORPORATION 510(k) NO: K070961(TRADITIONAL)
ATTN: CHRISTINA L KICHULA PHONE NO : 301-998-6152
1700 ROCKVILLE PIKE SE DECISION MADE: 25-FEB-08
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
ROCKVILLE, MD 20852
DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM310
BIONIME CORPORATION 510(k) NO: K072054(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 28-FEB-08
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOMEWAVE NEUROMODULATIONS PAIN THERAPY DEVICE
BIOWAVE CORPORATION 510(k) NO: K072123(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 01-FEB-08
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRO-V
BISCO, INC. 510(k) NO: K073263(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 14-FEB-08
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLACKSTONE ASCENT MULTIAXIAL SCREWS
BLACKSTONE MEDICAL, INC. 510(k) NO: K073420(SPECIAL)
ATTN: WHITNEY G TORNING PHONE NO : 973-406-2838
1211 HAMBURG TURNPIKE SE DECISION MADE: 14-FEB-08
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WAYNE, NJ 07470
DEVICE: WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
BOSTON SCIENTIFIC CORP. 510(k) NO: K073266(TRADITIONAL)
ATTN: NEIL KELLY PHONE NO : 508-683-4872
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 27-FEB-08
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
BREAS MEDICAL AB 510(k) NO: K071702(TRADITIONAL)
ATTN: IBB JESSEN PHONE NO : 011 463 1868800
FORETAGSVAGEN 1 SE DECISION MADE: 15-FEB-08
MOLNLYCKE, SWEDEN 435 33 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. POWER CHAIR, MODEL HS-1500
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K073686(TRADITIONAL)
ATTN: LINDA J BOVARD PHONE NO : 541-345-5431
29611 SIMMONS ROAD SE DECISION MADE: 27-FEB-08
EUGENE, OR 97405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGEGRID
CANDELIS, INC. 510(k) NO: K080333(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 22-FEB-08
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
CARDIOVASCULAR IMAGING SOLUTIONS L510(k) NO: K073194(TRADITIONAL)
ATTN: CARL THOMAS PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 14-FEB-08
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORE-SIGHT, MC-2000 SERIES
CAS MEDICAL SYSTEMS, INC. 510(k) NO: K073036(TRADITIONAL)
ATTN: RON JEFFREY PHONE NO : 203-488-6056
44 EAST INDUSTRIAL RD. SE DECISION MADE: 25-FEB-08
BRANFORD, CT 06405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APERFIX INTERFERENCE SCREW 7-12 MM X 20 MM; 7-12 MM X 25 MM; 7-1
CAYENNE MEDICAL, INC. 510(k) NO: K073426(TRADITIONAL)
ATTN: KERESHMEH SHAHRIARI PHONE NO : 480-502-3661
16597 N. 92ND STREET SE DECISION MADE: 19-FEB-08
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
SCOTTSDALE, AZ 85260
DEVICE: ORIA NATURA SPACER
CHOICE SPINE, LP 510(k) NO: K073669(TRADITIONAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457
8202 SHERMAN ROAD SE DECISION MADE: 13-FEB-08
CHESTERLAND, OH 44026-2141 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIBA VISION (LOTRAFILCON B) SOFT CONTACT LENSES
CIBA VISION CORPORATION 510(k) NO: K073459(TRADITIONAL)
ATTN: ALICIA M PLESNARSKI PHONE NO : 678-415-3924
11460 JOHNS CREEK PARKWAY SE DECISION MADE: 28-FEB-08
DULUTH, GA 30097 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) C
CLEARSTREAM TECHNOLOGIES, LTD. 510(k) NO: K072947(TRADITIONAL)
ATTN: IAN P GORDON PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 08-FEB-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: POLYSTAR 79 DENTURE BASE RESIN
CMP INDUSTRIES LLC. 510(k) NO: K072851(TRADITIONAL)
ATTN: DEVON O HOWE PHONE NO : 518-434-3147
413 NORTH PEARL ST. SE DECISION MADE: 20-FEB-08
ALBANY, NY 12207 510(k) STATEMENT
DEVICE: VF LONG TERM
COAPT SYSTEMS, INC. 510(k) NO: K071663(TRADITIONAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7647
1820 EMBARCADERO RD. SE DECISION MADE: 15-FEB-08
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAWOUND HYDROGEL
COLLAMATRIX CO., INC. 510(k) NO: K071557(TRADITIONAL)
ATTN: DENNIS J.N. SEAH PHONE NO : 886 2 77209988
NO. 360 RUIGUANG ROAD, 2ND FL. SE DECISION MADE: 08-FEB-08
NEIHU DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI, CHINA (TAIWAN) 114
DEVICE: VENA CAVA FILTER
COOK INCORPORATED 510(k) NO: K073528(SPECIAL)
ATTN: MOLLY BUSENBANK PHONE NO : 812-339-2235
750 DANIELS WAY, P.O. BOX 489 SE DECISION MADE: 27-FEB-08
BLOOMINGTON, IN 47402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C0
CORDIS CORP. 510(k) NO: K062798(TRADITIONAL)
ATTN: KAREN WILK PHONE NO : 980-412-7257
7 POWDER HORN DRIVE SE DECISION MADE: 06-FEB-08
WARREN, NJ 07059 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EEG NEUROAMP, MODEL CS10137
CORSCIENCE GMBH & CO. KG 510(k) NO: K073557(TRADITIONAL)
ATTN: CHRISTINE BAUMANN PHONE NO : 49 913 197798625
HENKESTRASSE 91 SE DECISION MADE: 28-FEB-08
ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS IMPLANT SYSTEM
COWELL MEDI CO., LTD. 510(k) NO: K071148(TRADITIONAL)
ATTN: CHANG D KYU PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 06-FEB-08
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: HUMAN HEART VALVE, CRYOVALVE SG
CRYOLIFE, INC. 510(k) NO: K033484(TRADITIONAL)
ATTN: DAVID M FRONK PHONE NO : 678-290-4303
1655 ROBERTS BLVD., N.W. SE DECISION MADE: 07-FEB-08
KENNESAW, GA 30144 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AFFIRM WITH XPL HANDPIECE AND ER:YAG LASER MODULE
CYNOSURE, INC. 510(k) NO: K080006(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 28-FEB-08
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
DADE BEHRING, INC. 510(k) NO: K073072(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891
GLASGOW BUSINESS COMMUNITY; SE DECISION MADE: 21-FEB-08
BLDG. 500 MAIL BOX 514 510(k) SUMMARY AVAILABLE FROM FDA
P.O. BOX 6101, NEWARK, DE 19714-6101
DEVICE: DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE,
DADE BEHRING, INC. 510(k) NO: K073561(TRADITIONAL)
ATTN: HELEN M LEE PHONE NO : 302-631-8706
P.O BOX 6101, MS514 SE DECISION MADE: 26-FEB-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUAYI H035 BASIC WHEELCHAIR
DANYANG HUAYI MEDICAL SUPPLY & EQU510(k) NO: K080114(TRADITIONAL)
ATTN: NORMAN F ESTRIN PHONE NO : 301-279-2899
9109 COPENHAVER DRIVE SE DECISION MADE: 15-FEB-08
POTOMAC, MD 20854 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K073067(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 15-FEB-08
W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: ANKYLOS TEMPORARY ABUTMENT BALANCE
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K073073(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
SUSQUEHANNA COMMERCE CTR., 221 SE DECISION MADE: 12-FEB-08
W. PHILADELPHIA ST., SUITE 60 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: DEPUY TRI-LOCK BONE PRESERVATION STEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K073570(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 21-FEB-08
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL
DIAZYME LABORATORIES 510(k) NO: K072270(TRADITIONAL)
ATTN: CHARLES YU PHONE NO : 858-455-4761
12889 GREGG COURT SE DECISION MADE: 01-FEB-08
POWAY, CA 92064 510(k) STATEMENT
DEVICE: LIMITED ARTIFACT SKULL PIN, MODEL 0107
DINKLER SURGICAL DEVICES, INC. 510(k) NO: K073163(TRADITIONAL)
ATTN: CHARLES E DINKLER II PHONE NO : 513-310-0017
174 LOOKOUT DRIVE SE DECISION MADE: 28-FEB-08
DAYTON, OH 45419 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SE
DRAGER MEDICAL AG & CO. KGAA 510(k) NO: K072412(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 215-660-2078
3135 QUARRY ROAD SE DECISION MADE: 06-FEB-08
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DVO EXTENDED ARTICULATION HUMERAL HEADS
DVO EXTREMITY SOLUTIONS, LLC 510(k) NO: K073331(TRADITIONAL)
ATTN: JEFF ONDRLA PHONE NO : 574-527-9951
720 E WINONA AVE SE DECISION MADE: 19-FEB-08
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EBI INTERNAL IMPLANT SYSTEM
EBI, INC. 510(k) NO: K073116(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 28-FEB-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELLMAN NOBLE ALLOY ELECTRODES
ELLMAN INTERNATIONAL, INC. 510(k) NO: K071343(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320
543 LONG HILL AVENUE SE DECISION MADE: 28-FEB-08
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
ENDIUS, INC. 510(k) NO: K073510(TRADITIONAL)
ATTN: REGINA WAGNER PHONE NO : 508-643-0983
23 WEST BACON ST. SE DECISION MADE: 11-FEB-08
PLAINVILLE, MA 02762 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVOYCEM, MODEL 1640
ENVOY MEDICAL CORPORATION 510(k) NO: K080032(TRADITIONAL)
ATTN: BERNARD (BUD) HORWATH PHONE NO : 651-361-8000
5000 TOWNSHIP PARKWAY SE DECISION MADE: 28-FEB-08
SAINT PAUL, MN 55110 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RK EPIDURAL NEEDLE
EPIMED INTERNATIONAL 510(k) NO: K072005(TRADITIONAL)
ATTN: KATIE ALEXANDER PHONE NO : 518-725-0209
141 SAL LANDRIO DR. SE DECISION MADE: 07-FEB-08
JOHNSTOWN, NY 12095 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ANCHORAGE CLOSURE DEVICE
EPITEK, INC. 510(k) NO: K073096(TRADITIONAL)
ATTN: WERNER HAMPL PHONE NO : 952-230-9886
4801 W. 81ST STREET SE DECISION MADE: 07-FEB-08
SUITE 105 510(k) SUMMARY AVAILABLE FROM FDA
BLOOMINGTON, MN 55437
DEVICE: CLEARSCAN
ESI, INC. 510(k) NO: K080119(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 21-FEB-08
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ETHICON ENDO SURGERY ARTICULATING NEEDLE KNIFE, MODEL 2504
ETHICON ENDO-SURGERY, INC. 510(k) NO: K073046(TRADITIONAL)
ATTN: GLENDA C MARSH PHONE NO : 513-337-7659
4545 CREEK RD. SE DECISION MADE: 25-FEB-08
CINCINNATI, OH 45242-2839 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE
FOX HOLLOW TECHNOLOGIES 510(k) NO: K071432(TRADITIONAL)
ATTN: MELISSA S MURPHY PHONE NO : 650-421-8579
740 BAY ROAD SE DECISION MADE: 12-FEB-08
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
FUJIFILM MEDICAL SYSTEMS USA, INC.510(k) NO: K073650(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 06-FEB-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMAFLEX SYSTEM, VERSION 3.20
GAMBRO 510(k) NO: K072093(TRADITIONAL)
ATTN: THOMAS B DOWELL PHONE NO : 303-231-4094
10810 W. COLLINS AVE. SE DECISION MADE: 01-FEB-08
LAKEWOOD, CO 80215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT T
GAMBRO RENAL PRODUCTS 510(k) NO: K072908(TRADITIONAL)
ATTN: FEI LAW PHONE NO : 386-481-1110
1845 MASON AVE. SE DECISION MADE: 04-FEB-08
DAYTONA BEACH, FL 32117-5102 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC AADVA ABUTMENT
GC AMERICA, INC. 510(k) NO: K072100(ABBREVIATED)
ATTN: H. CARL JENKINS PHONE NO : 847-234-7500
1025 EVERETT ROAD, SUITE 100 SE DECISION MADE: 14-FEB-08
LAKE FOREST, IL 60045 510(k) STATEMENT
DEVICE: GC GAM-100
GC AMERICA, INC. 510(k) NO: K073283(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 20-FEB-08
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: GC MODELS OPA-100 AND JC-50
GC AMERICA, INC. 510(k) NO: K073588(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-897-4042
3737 WEST 127TH ST. SE DECISION MADE: 15-FEB-08
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: CARDIQ EXPRESS VERSION 2.0
GE MEDICAL SYSTEMS 510(k) NO: K073138(TRADITIONAL)
ATTN: STEPHEN SLAVENS PHONE NO : 262-548-4992
3000 NORTH GRANDVIEW BLVD. SE DECISION MADE: 26-FEB-08
WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CARDIQ FUNCTION EXPRESS
GE MEDICAL SYSTEMS SCS 510(k) NO: K073153(TRADITIONAL)
ATTN: PHONE NO :
283 RUE DE LA MINIERE BP 34 SE DECISION MADE: 26-FEB-08
BUC CEDEX, FRANCE 78533 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: FACTS HAND AND PINCH GRIP COMBO
GLOBAL SERVICES GROUP, LLC 510(k) NO: K073154(TRADITIONAL)
ATTN: RAY GAGNE PHONE NO : 757-220-8282
350 MCLAWS CIRCLE SE DECISION MADE: 14-FEB-08
SUITE 2 510(k) STATEMENT
WILLIAMSBURG, VA 23185
DEVICE: HEARTSTRING III PROXIMAL SEAL SYSTEM
GUIDANT CORPORATION, CARDIAC SURGE510(k) NO: K080169(TRADITIONAL)
ATTN: ELIZABETH TRUJILLO PHONE NO : 408-635-6835
170 BAYTECH DRIVE SE DECISION MADE: 08-FEB-08
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HRI 6500, 6600 AND 6700 SERIES V2MASKS
HANS RUDOLPH, INC. 510(k) NO: K071149(TRADITIONAL)
ATTN: KEVIN RUDOLPH PHONE NO : 816-363-5522
7205 CENTRAL SE DECISION MADE: 01-FEB-08
KANSAS CITY, MO 64114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPO
HAROD ENTERPRISES, INC. 510(k) NO: K073576(TRADITIONAL)
ATTN: NORRIS R HAROD PHONE NO : 706-228-5165
4052 INDIAN CREEK ROAD SE DECISION MADE: 22-FEB-08
MARTINEZ, GA 30907 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO:HEALTH BUDDY APPLIANCE
HEALTH HERO NETWORK, INC. 510(k) NO: K080091(SPECIAL)
ATTN: ROBIN BUSH SAWAMURA PHONE NO : 650-690-9191
2400 GENG ROAD SE DECISION MADE: 05-FEB-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94303
DEVICE: HEANY INDUSTRIES INC DENTAL XIRCONIA
HEANY INDUSTRIES INC 510(k) NO: K073314(TRADITIONAL)
ATTN: COREY DUNN PHONE NO : 585-889-2700
249 BRIARWOOD LANE SE DECISION MADE: 21-FEB-08
SCOTTSVILLE, NY 14546 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTWAY POWER MOBILITY SCOOTER, PF7
HEARTWAY MEDICAL PRODUCTS CO., LTD510(k) NO: K080242(TRADITIONAL)
ATTN: JEN KE-MIN PHONE NO : 886 352 08829
NO.58, FU-CHIUN ST. SE DECISION MADE: 27-FEB-08
HSIN-CHU CITY, CHINA (TAIWAN) 408 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEUN
HERAEUS KULZER GMBH 510(k) NO: K073554(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 04-FEB-08
SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COI
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K080062(TRADITIONAL)
ATTN: DOUG THISTLEWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 11-FEB-08
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VARIAX ELBOW SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K073527(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DR. SE DECISION MADE: 14-FEB-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HOFFMANN LIGHT SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K073076(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DRIVE SE DECISION MADE: 15-FEB-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: V-RASER DIODE LASER SYSTEM
HOYA CONBIO, INC 510(k) NO: K073332(TRADITIONAL)
ATTN: LIZA BURNS PHONE NO : 209-586-0416
19722 WESTVIEW DRIVE SE DECISION MADE: 14-FEB-08
TWAIN HARTE, CA 95383 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EI DOWNPAK BARRIER SLEEVES
HU-FRIEDY MFG. CO., INC 510(k) NO: K073369(TRADITIONAL)
ATTN: KEITH DUNN PHONE NO : 773-975-3975
3232 N. ROCKWELL STREET SE DECISION MADE: 27-FEB-08
CHICAGO, IL 60618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAVE STOPCOCK
ICU MEDICAL, INC 510(k) NO: K080077(TRADITIONAL)
ATTN: TRACY BEST PHONE NO : 801-264-1332
4455 ATHERTON DR. SE DECISION MADE: 13-FEB-08
SALT LAKE CITY, UT 84123 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORTICAL HEALTH INDEX MONITOR, MODEL: I-2000 CIM MONITOR
INFINITE BIOMEDICAL TECHNOLOGIES 510(k) NO: K072382(TRADITIONAL)
ATTN: MANAN HATHI PHONE NO : 410-889-8011
3600 CLIPPER MILL ROAD SE DECISION MADE: 15-FEB-08
SUITE 410 510(k) SUMMARY AVAILABLE FROM FDA
BALTIMORE, MD 21211
DEVICE: QUANTA PLEX CELIAC IGG PROFILE
INOVA DIAGNOSTICS, INC. 510(k) NO: K072632(TRADITIONAL)
ATTN: BRYS C MYERS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 11-FEB-08
SAN DIEGO, CA 92131-1638 510(k) STATEMENT
DEVICE: QUANTA LITE H-TTG SCREEN
INOVA DIAGNOSTICS, INC. 510(k) NO: K073145(TRADITIONAL)
ATTN: JOSEPH PHILLIPS PHONE NO : 858-586-9900
9900 OLD GROVE RD. SE DECISION MADE: 12-FEB-08
SAN DIEGO, CA 92131-1638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMART COUPLER, MODEL M015401
INTELLIGENT HEARING SYSTEMS 510(k) NO: K073384(TRADITIONAL)
ATTN: EDWARD MISKIEL PHONE NO : 305-668-6102
6860 S.W. 81ST ST. SE DECISION MADE: 28-FEB-08
MIAMI, FL 33143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VN415M, VN415B, VO425M, V0425B, 2D-VOG GOGGLES, 2D-VOG SYSTEM
INTERACOUSTICS A/S 510(k) NO: K072254(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-903-4157
7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 05-FEB-08
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTR
INTUITIVE SURGICAL, INC. 510(k) NO: K070947(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 14-FEB-08
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAY
INTUITIVE SURGICAL, INC. 510(k) NO: K072211(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 28-FEB-08
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND E
INTUITIVE SURGICAL, INC. 510(k) NO: K072627(TRADITIONAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 07-FEB-08
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INVIROLINK AND INVIRO TIP BLUNT CANNULAS, MODEL 130001, 130501,
INVIRO MEDICAL DEVICES, INC. 510(k) NO: K071307(TRADITIONAL)
ATTN: JIM BARLEY PHONE NO : 770-291-2186
3235 SATELLITE BLVD. SE DECISION MADE: 12-FEB-08
BLDG. 400, STE. 300 510(k) SUMMARY AVAILABLE FROM FDA
DULUTH, GA 30096
DEVICE: SINGLE STEP MEDIUM
IRVINE SCIENTIFIC SALES CO., INC. 510(k) NO: K072609(TRADITIONAL)
ATTN: WENDELL LEE PHONE NO : 800-437-5706
2511 DAIMLER ST SE DECISION MADE: 12-FEB-08
SANTA ANA, CA 92705 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: I-DIXEL
J. MORITA USA, INC. 510(k) NO: K073704(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070
1425 K ST. N.W. SE DECISION MADE: 21-FEB-08
SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005
DEVICE: NTRAINER SYSTEM
KCBIOMEDIX, INC. 510(k) NO: K071866(TRADITIONAL)
ATTN: JAMES E STANLEY PHONE NO : 816-550-4510
4200 SW SAPELO DR. SE DECISION MADE: 01-FEB-08
LEES SUMMIT, MO 64082 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, S
KENSEY NASH CORPORATION 510(k) NO: K073162(SPECIAL)
ATTN: ROBIN FATZINGER PHONE NO : 484-713-2146
735 PENNSYLVANIA DRIVE SE DECISION MADE: 08-FEB-08
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK INTRODUCER KITS
KIMBERLY-CLARK CORP. 510(k) NO: K080253(SPECIAL)
ATTN: SHERRY SAURINI PHONE NO : 770-587-8502
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 26-FEB-08
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NONCON ROBO PACHY F&AKONAN MEDICAL, INC. 510(k) NO: K062763(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SOUTH SE DECISION MADE: 22-FEB-08
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG
KYPHON, INC. 510(k) NO: K073516(TRADITIONAL)
ATTN: PAMELA SEGALE PHONE NO : 408-548-5421
1221 CROSSMAN AVE. SE DECISION MADE: 21-FEB-08
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANDREL GUIDEWIRES OR M-WIRES
LAKE REGION MFG., INC. 510(k) NO: K080144(SPECIAL)
ATTN: DEEP PAL PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 26-FEB-08
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAR 55
LARSEN & TOUBRO LIMITED 510(k) NO: K080173(TRADITIONAL)
ATTN: S.B. BHOSALE PHONE NO : 847-303-3902
1051 PERIMETER DRIVE SE DECISION MADE: 08-FEB-08
SUITE 470 510(k) SUMMARY AVAILABLE FROM FDA
SCHAUMBURG, IL 60173 THIRD PARTY REVIEW
DEVICE: LEONE ORTHODONTIC MINI IMPLANT
LEONE SPA 510(k) NO: K071490(TRADITIONAL)
ATTN: ELIA LADANI PHONE NO : 39 055 30441
50, VIA P. A QUARACCHI SE DECISION MADE: 22-FEB-08
SESTO, FIORENTINO, ITALY I-50019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE
LEONHARD LANG GMBH 510(k) NO: K080106(SPECIAL)
ATTN: ELAINE DUNCAN PHONE NO : 715-549-6035
P.O. BOX 560 SE DECISION MADE: 01-FEB-08
STILLWATER, MN 55082-0560 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
LIGHT BIOSCIENCE, LLC 510(k) NO: K062991(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH STREET NW SE DECISION MADE: 15-FEB-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER AND ACCESSORIES
MASIMO CORPORATION 510(k) NO: K073024(SPECIAL)
ATTN: MARGUERITE THOMLINSON PHONE NO : 949-297-7000
40 PARKER SE DECISION MADE: 08-FEB-08
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD
MEDACTA INTERNATIONAL, SA 510(k) NO: K072857(TRADITIONAL)
ATTN: PAMELA J WEAGRAFF PHONE NO : 508-528-1745
18 BIRDIE LANE SE DECISION MADE: 04-FEB-08
NORFOLK, MA 02056 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MECTACER BIOLOX FORTE-FEMORAL HEADS
MEDACTA INTERNATIONAL, SA 510(k) NO: K073337(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 13-FEB-08
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AG-CLASSIC
MEDEL S.P.A. 510(k) NO: K072494(ABBREVIATED)
ATTN: TERRANCE M O'BRIEN PHONE NO : 919-468-9552
112 CAVISTION WAY SE DECISION MADE: 12-FEB-08
CARY, NC 27519 510(k) STATEMENT
DEVICE: EASYRA CHOLESTEROL REAGENT; EASYRA CALCIUM REAGENT REAGENT
MEDICA CORP. 510(k) NO: K072249(TRADITIONAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT STREET SE DECISION MADE: 20-FEB-08
BEVERLY, MA 01915 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APEX DAL ELECTRONIC APEX LOCATOR
MEDICNRG LTD. 510(k) NO: K080113(SPECIAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116
291 HILLSIDE AVE. SE DECISION MADE: 15-FEB-08
SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PENTABORN
MEDISCITEC INC. 510(k) NO: K072447(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
13 RED FOX LANE SE DECISION MADE: 15-FEB-08
LITTLETON, CO 80127 510(k) STATEMENT
DEVICE: MEDLINE DISPOSABLE VAGINAL SPECULUM
MEDLINE INDUSTRIES, INC. 510(k) NO: K072942(TRADITIONAL)
ATTN: MATT CLAUSEN PHONE NO : 847-643-4785
ONE MEDLINE PL. SE DECISION MADE: 08-FEB-08
MUNDELEIN, IL 60060 510(k) STATEMENT
DEVICE: INSTARAD
MEDSPHERE TECHNOLOGIES PVT LTD. 510(k) NO: K080334(TRADITIONAL)
ATTN: CARL ALLETTO PHONE NO : 940-300-8601
1600 MANCHESTER WAY SE DECISION MADE: 21-FEB-08
CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114
MEGA MOTION, INC. 510(k) NO: K080288(SPECIAL)
ATTN: TOM AMICO PHONE NO : 888-415-1200
957 WOOD ST. SE DECISION MADE: 15-FEB-08
OLD FORGE, PA 18518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERITS E600 SERIES STAIR LIFT
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K073110(TRADITIONAL)
ATTN: STEVE CHAO PHONE NO : 886 423 594985
9, ROAD 36 SE DECISION MADE: 06-FEB-08
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: THUMPER, MODEL: 1008
MICHIGAN INSTRUMENTS, INC. 510(k) NO: K073079(TRADITIONAL)
ATTN: HOWARD M HOSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST., NW SE DECISION MADE: 14-FEB-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS MICROCOIL SYSTEMS
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K073442(TRADITIONAL)
ATTN: JULIA GROSS PHONE NO : 408-433-1408
821 FOX LANE SE DECISION MADE: 26-FEB-08
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MILTEX RIGID CONTAINER SYSTEMS
MILTEX, INC. 510(k) NO: K072563(TRADITIONAL)
ATTN: PATRICIA KIHN PHONE NO : 717-840-3431
589 DAVIES DRIVE SE DECISION MADE: 12-FEB-08
YORK, PA 17402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHFAST NTPROBNP AND D-DIMER TESTS
MITSUBISHI KAGAKU IATRON 510(k) NO: K072189(TRADITIONAL)
ATTN: HELEN LANDICHO PHONE NO : 206-262-7364
701 FIFTH AVENUE SE DECISION MADE: 05-FEB-08
FLOOR 42 510(k) STATEMENT
SEATTLE, WA 98104
DEVICE: MINITAPE URETHRAL SLING
MPATHY MEDICAL DEVICES, LTD. 510(k) NO: K073646(SPECIAL)
ATTN: LOUIS J MAZZARESE PHONE NO : 203-318-8270
24 BARBERRY LANE SE DECISION MADE: 25-FEB-08
MADISON, CT 06443 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYGNAL DBM
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K073329(TRADITIONAL)
ATTN: NANCY BENNEWITZ PHONE NO : 732-661-2381
125 MAY ST, STE 300 SE DECISION MADE: 28-FEB-08
EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA
EDISON, NJ 08837
DEVICE: MUSMATE WALKING AID
MUSMATE LTD 510(k) NO: K073521(TRADITIONAL)
ATTN: ANDREW JAMES WYND PHONE NO : 44 176 1434234
4 FORD ROAD SE DECISION MADE: 04-FEB-08
PEASEDOWN ST JOHN 510(k) SUMMARY AVAILABLE FROM FDA
BATH, SOMERSET, UNITED KINGDOM BA2 8DG
DEVICE: PRIMEVUE 21" 3MP COLOR DISPLAY, MODEL AC-QX21-A9300
NDS SURGICAL IMAGING 510(k) NO: K080320(TRADITIONAL)
ATTN: JIM LANG PHONE NO : 408-776-0085
5750 HELLYER AVENUE SE DECISION MADE: 21-FEB-08
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NEOMED SINGLE LUMEN UMBILICAL CATHETER
NEOMED, INC. 510(k) NO: K073596(TRADITIONAL)
ATTN: PENNY NORTHCUTT PHONE NO : 678-428-6978
717 LAKEGLEN DR. SE DECISION MADE: 22-FEB-08
SUWANEE, GA 30024 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEOTRACT ANCHOR SYSTEM
NEOTRACT, INC. 510(k) NO: K073651(TRADITIONAL)
ATTN: SUZAN MOSER PHONE NO : 925-401-0627
4473 WILLOW ROAD SE DECISION MADE: 01-FEB-08
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94588
DEVICE: MODIFICATION TO:NESS L300
NESS-NEUROMUSCULAR ELECTRICAL STIM510(k) NO: K080219(SPECIAL)
ATTN: EVAN ROSENFELD PHONE NO : 661-362-4856
25103 RYE CANYON LOOP SE DECISION MADE: 28-FEB-08
VALENCIA, CA 91355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWDEAL TIBIAXYS SYSTEM
NEWDEAL SAS 510(k) NO: K073375(TRADITIONAL)
ATTN: JUDITH O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DR. SE DECISION MADE: 21-FEB-08
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
NIHON KOHDEN AMERICA, INC. 510(k) NO: K080342(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 26-FEB-08
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7
NIHON SEIMITSU SOKKI CO., LTD. 510(k) NO: K071596(TRADITIONAL)
ATTN: KOJI KUBO PHONE NO : 814 254 81253
3F, 2-17-6 AKEBONO-CHO SE DECISION MADE: 15-FEB-08
TACHIKAWA- SHI, JAPAN 190-0012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
NIPRO MEDICAL CORPORATION 510(k) NO: K072988(TRADITIONAL)
ATTN: JESSICA OSWALD PHONE NO : 305-599-7174
3150 N.W. 107TH AVE. SE DECISION MADE: 21-FEB-08
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOBELACTIVE ZIRCONIA ABUTMENT
NOBEL BIOCARE AB 510(k) NO: K072129(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
22715 SAVI RANCH PKWY. SE DECISION MADE: 22-FEB-08
YORBA LINDA, CA 92887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS IGM REAGENT
OLYMPUS AMERICA INC. 510(k) NO: K073487(TRADITIONAL)
ATTN: STEPHANIE G DONNELLY PHONE NO : 972 230 0959
LISMEEHAN, O, CALLAGHAN'S SE DECISION MADE: 11-FEB-08
MILLS 510(k) SUMMARY AVAILABLE FROM FDA
CO. CLARE, IRELAND
DEVICE: OLYMPUS IGA REAGENT
OLYMPUS AMERICA INC. 510(k) NO: K073489(TRADITIONAL)
ATTN: STEPHANIE G DONNELLY PHONE NO : 972 230 0959
LISMEEHAN, O, CALLAGHAN'S SE DECISION MADE: 11-FEB-08
MILLS 510(k) SUMMARY AVAILABLE FROM FDA
CO. CLARE, IRELAND
DEVICE: OLYMPUS IGG REAGENT
OLYMPUS AMERICA INC. 510(k) NO: K073490(TRADITIONAL)
ATTN: STEPHANIE G DONNELLY PHONE NO : 972 230 0959
LISMEEHAN, O, CALLAGHAN'S SE DECISION MADE: 11-FEB-08
MILLS 510(k) SUMMARY AVAILABLE FROM FDA
CO. CLARE, IRELAND
DEVICE: APEX-LNK POLY ACETABULAR CUP LINERS
OMNI LIFE SCIENCE, INC. 510(k) NO: K073150(SPECIAL)
ATTN: EDWARD J CHEAL PHONE NO : 508-824-2444
175 PARAMOUNT DRIVE SE DECISION MADE: 27-FEB-08
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: APEX KNEE SYSTEM
OMNLIFE SCIENCE 510(k) NO: K073602(SPECIAL)
ATTN: WILLIAM MCCALLUM PHONE NO : 508-824-2444
175 PARAMOUNT DRIVE SE DECISION MADE: 14-FEB-08
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 1500 PRO
OMRON HEALTHCARE, INC. 510(k) NO: K080289(SPECIAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK COURT #102 SE DECISION MADE: 26-FEB-08
BONITA SPRINGS, FL 34134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSK EXTREME MR SCANNER, MODEL AA5000
ONI MEDICAL SYSTEMS, INC. 510(k) NO: K080048(SPECIAL)
ATTN: MARK PUOPOLO PHONE NO : 978-658-0020
301 BALLARDVALE ST. SE DECISION MADE: 06-FEB-08
SUITE 4 510(k) SUMMARY AVAILABLE FROM FDA
WILMINGTON, MA 01887
DEVICE: PACIFICA
OR-NIM MEDICAL LTD. 510(k) NO: K073407(TRADITIONAL)
ATTN: CAMPBELL HUTTON PHONE NO : 202-822-1850
2001 PENNSYLVANIA AVE. NW SE DECISION MADE: 28-FEB-08
SUITE 950 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006
DEVICE: ORTHOPEDIATRICS PLATING SYSTEM
ORTHOPEDIATRICS, LLC 510(k) NO: K073344(TRADITIONAL)
ATTN: GARY BARNETT PHONE NO : 574-268-6379
210 NORTH BUFFALO STREET SE DECISION MADE: 19-FEB-08
WARSAW, IN 46580 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MS SYSTEM (DENTURE)
OSSTEM IMPLANT CO.,LTD 510(k) NO: K072959(TRADITIONAL)
ATTN: MIN JOO KIM PHONE NO : 215-736-2990
ONE BEN FAIRLESS DR. SE DECISION MADE: 04-FEB-08
FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
OSTEOMED L.P. 510(k) NO: K073065(TRADITIONAL)
ATTN: PIEDAD PENA PHONE NO : 972-677-4784
3885 ARAPAHO RD. SE DECISION MADE: 21-FEB-08
ADDISON, TX 75001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC
OSYPKA MEDICAL, INC. 510(k) NO: K070985(TRADITIONAL)
ATTN: MARKUS OSYPKA PHONE NO : 858-454-0021
7855 IVANHOE AVE., SUITE 226 SE DECISION MADE: 01-FEB-08
LA JOLLA, CA 92037 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PSL BIOZIR BLOCK
P.S.L. INTERNATIONAL INC. 510(k) NO: K073568(TRADITIONAL)
ATTN: CATHERINE FENG PHONE NO : 514 683 1731
1424 HYMUS, SUITE SE DECISION MADE: 06-FEB-08
DORVAL QUEBEC, CANADA H2P 1J6 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K063350(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291
KARL-HALL-STRASSE 01 SE DECISION MADE: 01-FEB-08
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS HEARTSTART SMARTPADS III
PHILIPS MEDICAL SYSTEMS 510(k) NO: K072812(TRADITIONAL)
ATTN: LARRY WALKER PHONE NO : 206-664-5896
2301 FIFTH AVE., SUITE 200 SE DECISION MADE: 26-FEB-08
SEATTLE, WA 98121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VINYL EXAMINATION GLOVE, POWDERED
PINNACLE CO., LTD. 510(k) NO: K072223(TRADITIONAL)
ATTN: DAVID DING PHONE NO : 86 533 7489957
240 RENMIN ROAD SE DECISION MADE: 21-FEB-08
LINZI 510(k) STATEMENT
SHANDONG, CHINA
DEVICE: VINYL EXAMINATION GLOVE POWDER FREE
PINNACLE CO., LTD. 510(k) NO: K072227(TRADITIONAL)
ATTN: DAVID DING PHONE NO : 865 337 489957
240 RENMIN ROAD SE DECISION MADE: 15-FEB-08
LINZI 510(k) STATEMENT
SHANDONG, CHINA
DEVICE: SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE)
PINNACLE CO., LTD. 510(k) NO: K072228(TRADITIONAL)
ATTN: DAVID DING PHONE NO : 865 337 489957
240 RENMIN ROAD SE DECISION MADE: 08-FEB-08
LINZI 510(k) STATEMENT
SHANDONG, CHINA
DEVICE: PRIMAEVA MEDICAL SYSTEM
PRIMAEVA MEDICAL, INC. 510(k) NO: K080145(SPECIAL)
ATTN: BRIAN GRIGSBY PHONE NO : 510-933-6090
42840 CHRISTY STREET SE DECISION MADE: 28-FEB-08
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
FREMONT, CA 94538
DEVICE: ORAL-B "SUB-BRAND" MANUAL TOOTHBRUSH
PROCTER & GAMBLE 510(k) NO: K073224(TRADITIONAL)
ATTN: MICHAEL A KAMINSKI PHONE NO : 513-622-2879
8700 MASON-MONTGOMERY RD. SE DECISION MADE: 06-FEB-08
MASON, OH 45040 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE
PROMIDENT LLC 510(k) NO: K080240(TRADITIONAL)
ATTN: GARY KRIS PHONE NO : 845-634-3997
242 NORTH MAIN ST. SE DECISION MADE: 07-FEB-08
NEW CITY, NY 10956 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: CYCLETRAC CT-5000
PT PRODUCTS, LLC 510(k) NO: K073542(TRADITIONAL)
ATTN: MICHELE CONWAY PHONE NO : 248-478-5820
24543 INDOPLEX CIRCLE SE DECISION MADE: 14-FEB-08
FARMINGTON HILLS, MI 48335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FAST1 INTRAOSSEOUS INFUSION SYSTEM
PYNG MEDICAL CORP. 510(k) NO: K072487(SPECIAL)
ATTN: MAYA BUTTERFIELD PHONE NO : 604 303 7964
#7-13511 CRESTWOOD PL SE DECISION MADE: 13-FEB-08
RICHMOND, B.C., CANADA V6V 2E9 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: Q-PLUS T
QUANTA SYSTEM, S.P.A. 510(k) NO: K073549(TRADITIONAL)
ATTN: ISABELLA CARRER PHONE NO : 390 331 37679
VIA IV NOVEMBRE,116 SE DECISION MADE: 28-FEB-08
SOLBIATE OLONA(VA), ITALY 21058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
RADI MEDICAL SYSTEMS AB 510(k) NO: K080206(SPECIAL)
ATTN: HELENE EKSTRAND PHONE NO : 46 18 161000
PALMBLADSGATAN 10 SE DECISION MADE: 26-FEB-08
UPPSALA, SWEDEN S-754 50 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOCT COPERNICUS, MODEL 15205
REICHERT, INC. 510(k) NO: K071839(TRADITIONAL)
ATTN: SANDRA BROWN PHONE NO : 716-686-4548
3362 WALDEN AVE. SE DECISION MADE: 27-FEB-08
DEPEW, NY 14043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIANCE BUTTRESS WASHER SYSTEM
RELIANCE MEDICAL SYSTEMS, LLC 510(k) NO: K073349(TRADITIONAL)
ATTN: BRET M BERRY PHONE NO : 801-718-7467
2647 CASSOWARY CIR SE DECISION MADE: 13-FEB-08
SANDY, UT 84092-7116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LED PRO SEAL
RELIANCE ORTHODONTIC PRODUCTS, INC510(k) NO: K073243(TRADITIONAL)
ATTN: PAUL GANGE PHONE NO : 630-773-4009
1540 WEST THORNDALE AVE. SE DECISION MADE: 08-FEB-08
ITASCA, IL 60143 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO-MAT 2000
RICHWAY INTL., INC. 510(k) NO: K072534(TRADITIONAL)
ATTN: LEROY KLIMA PHONE NO : 808-589-2800
1314 SOUTH KING ST., SUITE 520 SE DECISION MADE: 08-FEB-08
HONOLULU, HI 96814 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PVA PLUS VIAL PVA FOAM EMBOLIZATION PARTICLES, PVA PLUS CONVENIE
RJ MEDICAL, INC. 510(k) NO: K073419(TRADITIONAL)
ATTN: JIM INNES PHONE NO : 916-941-6913
4921 ROBERT J. MATHEWS PKWY SE DECISION MADE: 14-FEB-08
#2 510(k) SUMMARY AVAILABLE FROM FDA
EL DORADO HILLS, CA 95762
DEVICE: ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET
ROCHE DIAGNOSTICS 510(k) NO: K072437(TRADITIONAL)
ATTN: KAY TAYLOR PHONE NO : 317-521-3544
9115 HAGUE ROAD SE DECISION MADE: 05-FEB-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECSYS PROBNP II CALCHECK
ROCHE DIAGNOSTICS CORP. 510(k) NO: K080147(TRADITIONAL)
ATTN: KAY A TAYLOR PHONE NO : 317-521-3544
9115 HAGUE RD. SE DECISION MADE: 27-FEB-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANARUS V2 TREATMENT SYSTEM
SANARUS MEDICAL, INC. 510(k) NO: K073533(SPECIAL)
ATTN: LISA HENRY PHONE NO : 925-460-6080
4696 WILLOW RD. SE DECISION MADE: 07-FEB-08
PLEASANTON, CA 94588 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SANATMETAL NAILS AND PINS
SANATMETAL MFR. OF ORTHOPAEDIC/TRA510(k) NO: K070761(TRADITIONAL)
ATTN: DONALD GUTHNER PHONE NO : 888-674-3649
111 HILL ROAD SE DECISION MADE: 07-FEB-08
DOUGLASSVILLE, PA 19518 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATMATIC 31 HANDPIECE MAINTENANCE UNIT
SCICAN LTD. 510(k) NO: K073319(TRADITIONAL)
ATTN: BRENDA MURPHY PHONE NO : 416 446 2797
1440 DON MILLS RD. SE DECISION MADE: 04-FEB-08
TORONTO, ONTARIO, CANADA M3B 3P9 510(k) STATEMENT
DEVICE: PETERIO UNIVERSAL LASER SCANNING HANDPIECE
SCILEX, LTD. 510(k) NO: K073048(TRADITIONAL)
ATTN: ALEX RAPOPORT PHONE NO : 888 672 4539
ARLOZOROV 41A SE DECISION MADE: 28-FEB-08
RISHON LE ZION, ISRAEL 75214 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OCCLUSION BALLOON CATHETER
SENTREHEART INC. 510(k) NO: K070126(TRADITIONAL)
ATTN: LINDA GUTHRIE PHONE NO : 650-354-1200
2468 EMBARCADERO WAY SE DECISION MADE: 08-FEB-08
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TALKING CLINICAL ELECTRONIC THERMOMETER, MODELS DX6623B, DT1031
SHENZHEN DONGDIXIN TECHNOLOGY CO, 510(k) NO: K073366(TRADITIONAL)
ATTN: CHARLES MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 08-FEB-08
FLINTVILLE, TN 37335 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: BS-200 CHEMISTRY ANALYZER, MODE BS-200
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K072018(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 01-FEB-08
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAUTIFIL OPAQUER
SHOFU DENTAL CORP. 510(k) NO: K080068(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 28-FEB-08
SAN MARCOS, CA 92078 510(k) STATEMENT
DEVICE: ARTIS ZEE AND ZEEGO
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K073290(TRADITIONAL)
ATTN: GARY JOHNSON PHONE NO : 610-448-1778
51 VALLEY STREAM PKWY. SE DECISION MADE: 11-FEB-08
MS E-50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: SYNGO DUAL ENERGY WITH EXTENDED FUNCTIONALLY
SIEMENS MEDICAL SOLUTIONS, INC. 510(k) NO: K073003(SPECIAL)
ATTN: CORRINE MCLEOD PHONE NO : 610-448-1772
51 VALLEY STREAM PARKWAY SE DECISION MADE: 07-FEB-08
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERIOSCAN, MODEL: D 3496
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K072107(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO : 496 251 160
FABRIKSTRASSE 31 SE DECISION MADE: 14-FEB-08
BENSHEIM, GERMANY D-64625 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K073466(TRADITIONAL)
ATTN: MASON W ROBBINS PHONE NO : 901-399-6021
1450 E BROOKS ROAD SE DECISION MADE: 22-FEB-08
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
SMITHS MEDICAL ASD, INC. 510(k) NO: K073188(ABBREVIATED)
ATTN: BRIAN FARIAS PHONE NO : 603-357-3812
10 BOWMAN DR. SE DECISION MADE: 08-FEB-08
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-627
SMITHS MEDICAL MD, INC. 510(k) NO: K072955(TRADITIONAL)
ATTN: DAVID H SHORT PHONE NO : 651-628-7240
1265 GREY FOX RD. SE DECISION MADE: 13-FEB-08
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENSPLINTRX BONE FIXATION SYSTEM
SONOMA ORTHOPEDIC PRODUCTS, INC. 510(k) NO: K071809(TRADITIONAL)
ATTN: CHARLES L NELSON PHONE NO : 707-526-1335
650 LARKFIELD CENTER SE DECISION MADE: 21-FEB-08
SANTA ROSA, CA 95403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA HAIR REMOVAL LASER
SPECTRAGENICS, INC. 510(k) NO: K053527(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5600
555 THIRTEENTH STREET NW SE DECISION MADE: 01-FEB-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CIMPLICITY SPINAL SYSTEM
SPINE SMITH PARTNERS L.P. 510(k) NO: K073320(TRADITIONAL)
ATTN: ROBERT JONES PHONE NO : 512-302-0086
5300 NORTH LAMAR BLVD #107 SE DECISION MADE: 07-FEB-08
AUSTIN, TX 78751 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX
SPINEFRONTIER, INC. 510(k) NO: K073232(TRADITIONAL)
ATTN: THOMAS A CARLSON PHONE NO : 978-232-3990
100 CUMMINGS CENTER SE DECISION MADE: 20-FEB-08
SUITE 240C 510(k) SUMMARY AVAILABLE FROM FDA
BEVERLY, MA 01915
DEVICE: AQUA PURE DEIONIZER EXCHANGE SERVICE
STAUBACH BARROR WATER SYSTEMS, INC510(k) NO: K072158(TRADITIONAL)
ATTN: JARROD J STAUBACH PHONE NO : 518-355-4390
495 ROTTERDAM IND. PARK SE DECISION MADE: 21-FEB-08
SCHENECTADY, NY 12306 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED SCISSOR TIPS
STERILMED, INC. 510(k) NO: K073613(TRADITIONAL)
ATTN: JOSHUA CLARIN PHONE NO : 763-488-3483
11400 73RD AVE. NORTH, #100 SE DECISION MADE: 12-FEB-08
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NRBC-CHEX FOR ADVIA
STRECK 510(k) NO: K080016(TRADITIONAL)
ATTN: ERIN JOHNSON PHONE NO : 402-537-5311
7002 SOUTH 109TH ST. SE DECISION MADE: 05-FEB-08
OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THOR ANTERIOR PLATING SYSTEM
STRYKER SPINE 510(k) NO: K073437(TRADITIONAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201-760-8296
2 PEARL COURT SE DECISION MADE: 13-FEB-08
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO STRYKER SPINE OASYS SYSTEM
STRYKER SPINE 510(k) NO: K080143(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201-760-8296
2 PEARL COURT SE DECISION MADE: 14-FEB-08
ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIVE AND SHALLOW AND GRAND DIVE
SUMMIT TO SEA 510(k) NO: K072757(TRADITIONAL)
ATTN: BRUCE MCKEEMAN PHONE NO : 612-325-8243
1744 AVOCET LANE SE DECISION MADE: 08-FEB-08
MOUND, MN 55364 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
SYNTHES (USA) 510(k) NO: K073460(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY SE DECISION MADE: 21-FEB-08
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES ZERO-P
SYNTHES SPINE CO.LP 510(k) NO: K072981(TRADITIONAL)
ATTN: SUSAN LEWANDOWSKI PHONE NO : 610-719-5712
1302 WRIGHTS LANE EAST SE DECISION MADE: 11-FEB-08
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TERASON ECHO T/3000 ULTRASOUND SYSTEM WITH STRESS ECHO
TERATECH CORP. 510(k) NO: K080234(TRADITIONAL)
ATTN: PHONE NO :
77-79 TERRACE HALL AVE. SE DECISION MADE: 14-FEB-08
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS AN
THE BINDING SITE, LTD. 510(k) NO: K072889(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 01-FEB-08
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: SPECTRA MRSA
THERMO FISHER SCIENTIFIC 510(k) NO: K073027(TRADITIONAL)
ATTN: MARY ANN SILVIUS PHONE NO : 913-895-4054
12150 SANTA FE DRIVE SE DECISION MADE: 28-FEB-08
LENEXA, KS 66215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CALCIUM, SCAL, NORTROL, ABTROL
THERMO FISHER SCIENTIFIC OY 510(k) NO: K073355(TRADITIONAL)
ATTN: PAIVI SORMUNEN PHONE NO : 358 932 9100
2 RATASTIE SE DECISION MADE: 28-FEB-08
VANTAA, FINLAND FIN-01621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPI VARIOMULTI ABUTMENT
THOMMEN MEDICAL, AG 510(k) NO: K072856(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL, STE. 200 SE DECISION MADE: 15-FEB-08
SAN DIEGO, CA 92130 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K080160(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 08-FEB-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: 15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2)
TOTOKU ELECTRIC CO., LTD 510(k) NO: K071794(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 81 268 345469
300 OYA, UEDA SE DECISION MADE: 11-FEB-08
NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KODAK 9000, KODAK 9000 3D
TROPHY 510(k) NO: K073435(TRADITIONAL)
ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08526
4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 11-FEB-08
BEAUBOURG 510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77437
DEVICE: FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505
ULTRADENT PRODUCTS, INC. 510(k) NO: K080249(SPECIAL)
ATTN: DIANE ROGERS PHONE NO : 801-553-4491
505 WEST 10200 SOUTH SE DECISION MADE: 08-FEB-08
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FOX 940, MODEL 940
VALAM INC. 510(k) NO: K071896(TRADITIONAL)
ATTN: KIRSTEN PAULSON PHONE NO : 301-795-2639
3202 TOWER OAKS BLVD SUITE 300 SE DECISION MADE: 22-FEB-08
ROCKVILLE, MD 20852 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICOMPARTMENTAL KNEE
VALPO ORTHOPEDIC TECHNOLOGY, INC. 510(k) NO: K072704(TRADITIONAL)
ATTN: HANS STOVER PHONE NO : 574-269-4103
438 E 200 N SE DECISION MADE: 19-FEB-08
WARSAW, IN 46582 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
VASCULAR PATHWAYS 510(k) NO: K073241(ABBREVIATED)
ATTN: MARY PASCUAL GALLUP PHONE NO : 510-487-1561
713 SANDOVAL WAY SE DECISION MADE: 08-FEB-08
HAYWARD, CA 94544 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582
VASCULAR SOLUTIONS, INC. 510(k) NO: K073200(TRADITIONAL)
ATTN: JULIE TAPPER PHONE NO : 763-656-4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 01-FEB-08
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BR2 NASAL DILATOR, MODEL BR2
VENTUS MEDICAL, INC. 510(k) NO: K071560(TRADITIONAL)
ATTN: CINDY DOMECUS PHONE NO : 650-343-4813
1171 BARROILHET DRIVE SE DECISION MADE: 08-FEB-08
HILLSBOROUGH, CA 94010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENFIL ETCHANT-37
VERICOM CO., LTD. 510(k) NO: K080265(TRADITIONAL)
ATTN: MYUNG-HWAN OH PHONE NO : 82 31 4412881
#606,5TH DONGYOUNG VENTURESTEL SE DECISION MADE: 06-FEB-08
199-32, ANYANG 7-DONG,MANAN-GU 510(k) SUMMARY AVAILABLE FROM FDA
ANYANG-SI, GYEONGGI-DO, REPUBLIC OTHIRD PARTY REVIEW
DEVICE: WELL-PEX
VERICOM CO., LTD. 510(k) NO: K080266(TRADITIONAL)
ATTN: MYUNG-HWAN OH PHONE NO : 82 31 4412881
#606,5TH DONGYOUNG VENTURESTEL SE DECISION MADE: 06-FEB-08
199-32, ANYANG 7-DONG,MANAN-GU 510(k) SUMMARY AVAILABLE FROM FDA
ANYANG-SI, GYEONGGI-DO, REPUBLIC OTHIRD PARTY REVIEW
DEVICE: CELLSEARCH CIRCULATING TUMOR CELL KIT
VERIDEX, LLC 510(k) NO: K073338(TRADITIONAL)
ATTN: DEBRA J RASMUSSEN PHONE NO : 908-791-2438
1001 US HWY 202 SE DECISION MADE: 26-FEB-08
RARITAN, NJ 08869-0606 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXTENDED VERTIFLEX SPINAL SCREW SYSTEM
VERTIFLEX, INC. 510(k) NO: K073245(SPECIAL)
ATTN: STEVE REITZLER PHONE NO : 949-940-1434
1351 CALLE AVANZADA SE DECISION MADE: 15-FEB-08
SAN CLAMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITREA 4DCT
VITAL IMAGES, INC. 510(k) NO: K072821(TRADITIONAL)
ATTN: TIMOTHY J KNAPPERS PHONE NO : 952-487-9624
5850 OPUS PARKWAY, SE DECISION MADE: 20-FEB-08
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
MINNETONKA, MN 55343-4414 THIRD PARTY REVIEW
DEVICE: BONALIVE GRANULES
VIVOXID LTD. 510(k) NO: K071199(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6470 RIVERVIEW TERRACE SE DECISION MADE: 01-FEB-08
FRIDLEY, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DYNASTY CERAMIC FEMORAL HEAD
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K072656(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901-867-4350
5677 AIRLINE RD. SE DECISION MADE: 06-FEB-08
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIDEKICK RAIL FIXATOR
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K080071(SPECIAL)
ATTN: PEGGY S RIVERS PHONE NO : 901-867-4759
5677 AIRLINE RD. SE DECISION MADE: 07-FEB-08
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHARLOTTE CLAW 3.5
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K080295(SPECIAL)
ATTN: SARAH HOLTGREWE PHONE NO : 901-867-4476
5677 AIRLINE RD. SE DECISION MADE: 27-FEB-08
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MSTAR MPD4500
XINAOMDT TECHNOLOGY CO., LTD. 510(k) NO: K073457(TRADITIONAL)
ATTN: DIANE HONG PHONE NO : 862 164 264467
SUITE 8D ZHONGSHAN MANSION SE DECISION MADE: 01-FEB-08
LANE 999, ZHONGSHAN, NO.2 ROAD 510(k) STATEMENT
SHANGHAI, CHINA 200030 THIRD PARTY REVIEW
DEVICE: YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-1
YA HORNG ELECTRONIC CO., LTD. 510(k) NO: K072860(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 25-FEB-08
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUIKCLOT NOSEBLEED
Z-MEDICA CORPORATION 510(k) NO: K080247(TRADITIONAL)
ATTN: RONALD E PETERSON PHONE NO : 203-294-0000
4 FAIRFIELD BLVD. SE DECISION MADE: 27-FEB-08
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GUARDIAN HEMOSTASIS VALVE
ZERUSA LIMITED 510(k) NO: K073620(TRADITIONAL)
ATTN: GER BRETT PHONE NO : 011 353 91863061
219-220 BUSINESS INNOVATION SE DECISION MADE: 27-FEB-08
CENTRE NUIG, 510(k) SUMMARY AVAILABLE FROM FDA
GALWAY, IRELAND
DEVICE: MEDICAL GLOVE SERIES
ZHANJIANG JIALI GLOVE PRODUCTS CO.510(k) NO: K072145(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467
SUITE 8D, NO. 19, LANE 999 SE DECISION MADE: 26-FEB-08
ZHONGSHAN NO. 2 ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200030
DEVICE: DYNESYS TOP-LOADING SPINAL SYSTEM
ZIMMER SPINE, INC 510(k) NO: K073347(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952-830-6205
7375 BUSH LAKE RD. SE DECISION MADE: 08-FEB-08
MINNEAPOLIS, MN 55439-2027 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER MIS LIGHT
ZIMMER SPINE, INC. 510(k) NO: K080367(TRADITIONAL)
ATTN: ELSA A LINKE PHONE NO : 952-830-6205
7375 BUSH LAKE RD. SE DECISION MADE: 22-FEB-08
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 228
TOTAL WITH SUMMARIES 205
TOTAL WITH STATEMENTS 23
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