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&A KONAN 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
Updated March 5, 2008
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