SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE) 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD 01-APR-2008 THROUGH 30-APR-2008 DEVICE: AP MEDICAL SHARPS CONTAINERS 0,6-12 LT. A.B.M. ITALIA S.P.A 510(k) NO: K071517(ABBREVIATED)
ATTN: FRANCO GRAVA PHONE NO : 390 422 745900 VIA LNG. G. TALIERCIO, 1 SE DECISION MADE: 02-APR-08 RONCADELLE DI ORMELLE, ITALY 31024510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOX PLUS PTA CATHETER ABBOTT VASCULAR INC. 510(k) NO: K080925(SPECIAL)
ATTN: IVALEE COHEN PHONE NO : 408-845-0682 3200 LAKESIDE DRIVE SE DECISION MADE: 28-APR-08 SANTA CLARA, CA 95054 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE ABBOTT VASCULAR, INC. 510(k) NO: K072460(TRADITIONAL)
ATTN: MICHELE WALZ PHONE NO : 951-914-4544 26531 YNEZ ROAD SE DECISION MADE: 11-APR-08 TEMECULA, CA 92590-3731 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, E ADVANCED ORTHOPAEDIC SOLUTIONS, IN510(k) NO: K080408(TRADITIONAL)
ATTN: PAUL DONER PHONE NO : 310-533-9966 2444 205TH STREET, UNIT 5 SE DECISION MADE: 25-APR-08 TORRANCE, CA 90501 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VANTAGECATH INTRAVASCULAR CATHETER ADVANTAGE MEDICAL DEVICE 510(k) NO: K073471(TRADITIONAL)
ATTN: JAMES SMITH PHONE NO : 949-340-7261 28241 CROWN VALLEY PARKWAY SE DECISION MADE: 30-APR-08 SUITE 510 510(k) SUMMARY AVAILABLE FROM FDA LAGUNA NIGUEL, CA 92677 THIRD PARTY REVIEW DEVICE: AESCULAP PRIMELINE CONTAINER LTD. AESCULAP, INC. 510(k) NO: K073168(TRADITIONAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291 3773 CORPORATE PKWY. SE DECISION MADE: 28-APR-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AESCULAP ENDOSCOPIC CLIP SYTEM AESCULAP, INC. 510(k) NO: K080753(SPECIAL)
ATTN: LISA M BOYLE PHONE NO : 610-984-9274 3773 CORPORATE PKWY. SE DECISION MADE: 02-APR-08 CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM AGA MEDICAL CORP. 510(k) NO: K080757(SPECIAL)
ATTN: RASHMI BHUSHAN PHONE NO : 763-531-3066 5050 NATHAN LANE NORTH SE DECISION MADE: 18-APR-08 PLYMOUTH, MN 55442 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ALVEOLUS, INC. 510(k) NO: K072720(TRADITIONAL)
ATTN: TONY D ALEXANDER PHONE NO : 704-926-4837 9013 PERIMETER WOODS DRIVE SE DECISION MADE: 11-APR-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CHARLOTTE, NC 28216 DEVICE: ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM ALVEOLUS, INC. 510(k) NO: K080838(SPECIAL)
ATTN: TONY D ALEXANDER PHONE NO : 704-926-4846 9013 PERIMETER WOODS DRIVE SE DECISION MADE: 24-APR-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA CHARLOTTE, NC 28216 DEVICE: LIFE+CEL OR LIFECEL BATTERY AMCO INTERNATIONAL MANUFACTURING &510(k) NO: K073716(TRADITIONAL)
ATTN: ALEX HENDERSON PHONE NO : 303-646-3715 377 ZANE COURT SE DECISION MADE: 11-APR-08 HILLSIDE VILLAGE 510(k) SUMMARY AVAILABLE FROM FDA ELIZABETH, CO 80107 DEVICE: WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT CO AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K073219(TRADITIONAL)
ATTN: MONA INMAN PHONE NO : 952-933-6204 10700 BREN RD., WEST SE DECISION MADE: 10-APR-08 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVAT AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K080185(SPECIAL)
ATTN: MONA INMAN PHONE NO : 952-930-6204 10700 BREN RD., WEST SE DECISION MADE: 10-APR-08 MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICR ANACAPA TECHNOLOGIES, INC. 510(k) NO: K073547(TRADITIONAL)
ATTN: ILA DOSHI PHONE NO : 909-394-7795 301 E. ARROW HWY SE DECISION MADE: 23-APR-08 STE. 106 510(k) SUMMARY AVAILABLE FROM FDA SAN DIMAS, CA 91773 DEVICE: ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 ANGIOSCORE, INC. 510(k) NO: K080151(TRADITIONAL)
ATTN: KARIN J GASTINEAU PHONE NO : 510-933-7904 5055 BRANDIN COURT SE DECISION MADE: 25-APR-08 FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ANGIOTECH CVC ANGIOTECH PHARMACEUTICALS, INC. 510(k) NO: K073520(TRADITIONAL)
ATTN: TRUDY D ESTRIDGE PHONE NO : 703-796-8927 13921 PARK CENTER ROAD SE DECISION MADE: 11-APR-08 SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA HERNDON, VA 20171 DEVICE: ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE APATECH LTD. 510(k) NO: K080736(SPECIAL)
ATTN: CANDACE F CEDERMAN PHONE NO : 503-722-7494 15058 ARMEL DRIVE SE DECISION MADE: 16-APR-08 OREGON CITY, OR 97045 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 APEX BIOTECHNOLOGY CORP. 510(k) NO: K073137(TRADITIONAL)
ATTN: THOMAS Y.S. SHEEN PHONE NO : 011 886 35641952 NO. 7, LI-HSIN ROAD V, SE DECISION MADE: 01-APR-08 HSINCHU SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA HSINCHU, CHINA (TAIWAN) 30078 DEVICE: GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 APEX BIOTECHNOLOGY CORP. 510(k) NO: K073648(TRADITIONAL)
ATTN: THOMAS Y.S. SHEN PHONE NO : 011 886 35641952 NO. 7, LI-HSIN ROAD V, SE DECISION MADE: 10-APR-08 HSINCHU SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA HSINCHU, CHINA (TAIWAN) 30078 DEVICE: OSSEOSPEED NARROW ASTRA TECH AB 510(k) NO: K080396(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235 11234 EL CAMINO REAL, SE DECISION MADE: 30-APR-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA 92130 DEVICE: MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM ATCOR MEDICAL 510(k) NO: K080670(SPECIAL)
ATTN: JOHN ABRAM PHONE NO : 011 612 98748761 11/1059-1063 VICTORIA SE DECISION MADE: 23-APR-08 ROAD 510(k) SUMMARY AVAILABLE FROM FDA WEST RYDE NSW, AUSTRALIA 2114 DEVICE: C-QUR LITE MESH V-PATCH ATRIUM MEDICAL CORP. 510(k) NO: K080688(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 16-APR-08 HUDSON, NH 03051 510(k) STATEMENT DEVICE: C-QUR EDGE MESH V-PATCH ATRIUM MEDICAL CORP. 510(k) NO: K080691(SPECIAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433 5 WENTWORTH DR. SE DECISION MADE: 16-APR-08 HUDSON, NH 03051 510(k) STATEMENT DEVICE: ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS AXIS-SHIELD DIAGNOSTICS, LTD. 510(k) NO: K073640(TRADITIONAL)
ATTN: CLAIRE DORA PHONE NO : 004 401 382422000 THE TECHNOLOGY PARK SE DECISION MADE: 24-APR-08 DUNDEE, SCOTLAND, UNITED KINGDOM D510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS BARRX MEDICAL, INCORPORATED 510(k) NO: K080557(SPECIAL)
ATTN: VIORICA FILIMON PHONE NO : 408-328-7302 540 OAKMEAD PARKWAY SE DECISION MADE: 02-APR-08 SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRICOS T RESORBABLE BONE SUBSTITUTE BAXTER HEALTHCARE CORPORATION 510(k) NO: K073571(ABBREVIATED)
ATTN: BARBARA K BARBEAU PHONE NO : 847-473-6274 1620 WAUKEGAN ROAD SE DECISION MADE: 08-APR-08 MPGR-AL 510(k) SUMMARY AVAILABLE FROM FDA MCGAW PARK, IL 60085 DEVICE: CHROMOPHARE E-SERIES BERCHTOLD HOLDING GMBH 510(k) NO: K080857(TRADITIONAL)
ATTN: SILKE GORAL PHONE NO : 004 974 61181155 LUDWIGSTALER STRABE 25 SE DECISION MADE: 10-APR-08 TUTTLINGEN, GERMANY D-78532 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: 50W CERALAS D 1950NM DIODE LASER BIOLITEC, INC. 510(k) NO: K072682(TRADITIONAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794 555 THIRTEENTH ST., NW SE DECISION MADE: 18-APR-08 WASHINGTON, DC 20004-5910 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE BIOMERIEUX, INC. 510(k) NO: K080201(TRADITIONAL)
ATTN: JOLYN TENLLADO PHONE NO : 314-731-8386 595 ANGLUM RD. SE DECISION MADE: 30-APR-08 HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGENEREX TIBIAL COMPONENTS BIOMET, INC. 510(k) NO: K080361(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639 56 EAST BELL DR. P.O. BOX 587 SE DECISION MADE: 21-APR-08 WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD BIOSCAFFOLD INTERNATIONAL PTE LTD 510(k) NO: K080308(ABBREVIATED)
ATTN: ROGER GRAY PHONE NO : 390 657 82665 PIAZZA ALBANIA, 10 SE DECISION MADE: 14-APR-08 ROME, ITALY 00153 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-12 BIOSENSE WEBSTER, INC. 510(k) NO: K080425(TRADITIONAL)
ATTN: BALAKA DAS PHONE NO : 909-839-8599 3333 DIAMOND CANYON RD. SE DECISION MADE: 23-APR-08 DIAMOND BAR, CA 91765 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER BIPORE, INC. 510(k) NO: K073434(SPECIAL)
ATTN: KEITH PALUCH PHONE NO : 201-767-0435 31 INDUSTRIAL PKWY. SE DECISION MADE: 01-APR-08 NORTHVALE, NJ 07647 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BOVIE IDS-400 ELECTROSURGICAL GENERATOR BOVIE MEDICAL 510(k) NO: K072041(TRADITIONAL)
ATTN: RICHARD A KOZLOFF PHONE NO : 727-803-8513 3200 TYRONE BLVD., STE. A SE DECISION MADE: 10-APR-08 ST. PETERSBURG, FL 33710-2902 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIGITAL LIGHTBOX BRAINLAB, AG 510(k) NO: K080608(TRADITIONAL)
ATTN: RAINER BIRKENBACH PHONE NO : 498 991 5680 KAPELLENSTR. 12 SE DECISION MADE: 17-APR-08 FELDKIRCHEN, GERMANY 85622 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BT - TITE ONE OR CV1; STANDARD OR VSM; CV2; HA COATED STANDARD BTLOCK SRL 510(k) NO: K073458(TRADITIONAL)
ATTN: ESTER BATTILANA PHONE NO : 39 044 4492609 VIA MADONNETTA 97/C SE DECISION MADE: 04-APR-08 ALTE DI MONTECCHIO MAGGIORE, ITALY510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO:SPECIALTY NEEDLES BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K073222(SPECIAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711 75 ARKAY DRIVE SE DECISION MADE: 09-APR-08 P.O. BOX 11067 510(k) SUMMARY AVAILABLE FROM FDA HAUPPAUGE, NY 11788 DEVICE: CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEM CANDELA CORP. 510(k) NO: K073534(TRADITIONAL)
ATTN: LISA LACROIX PHONE NO : 508-358-7400 530 BOSTON POST ROAD SE DECISION MADE: 03-APR-08 WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CR-1 CANON, INC. 510(k) NO: K080883(TRADITIONAL)
ATTN: SHEILA DRISCOLL PHONE NO : 516-328-5602 ONE CANON PLAZA SE DECISION MADE: 24-APR-08 LAKE SUCCESS, NY 11042-1198 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM CARDINAL HEALTH 510(k) NO: K080845(TRADITIONAL)
ATTN: LAVENIA FORD PHONE NO : 847-785-3323 1500 WAUKEGAN RD. BLDG. WM SE DECISION MADE: 30-APR-08 MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PHLEBOTOMY BAG WITH VALVE & 17G X 1", MODEL CM-PH17X1B, CM-PH17X CARDIOMED SUPPLIES, INC. 510(k) NO: K080174(TRADITIONAL)
ATTN: CHRISTIAN G DUBE PHONE NO : 705 328 2518 199 ST. DAVID STREET SE DECISION MADE: 23-APR-08 LINDSAY-ONTARIO, CANADA K9V 5K7 510(k) STATEMENT DEVICE: IMAGENMD WITH IMAGENQ CARDIOVASCULAR IMAGING TECHNOLOGIE510(k) NO: K080770(TRADITIONAL)
ATTN: MELANIE HASEK PHONE NO : 913-410-2357 9755 RIDGE DR. SE DECISION MADE: 09-APR-08 LENEXA, KS 66219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVSTATIONIRAD EMT, VERSION 1.1 CAS INNOVATIONS AG 510(k) NO: K080624(TRADITIONAL)
ATTN: MARKUS NAGEL PHONE NO : 49 913 16166030 HEUTEG 47 SE DECISION MADE: 11-APR-08 ERLANGEN, GERMANY 91056 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CELL GEN LASER, MODEL CG-4000 CELL GEN THERAPEUTICS, LLC 510(k) NO: K080084(TRADITIONAL)
ATTN: DICK RIVERA PHONE NO : 214-914-2762 17734 PRESTON ROAD SE DECISION MADE: 21-APR-08 SUITE 204 510(k) SUMMARY AVAILABLE FROM FDA DALLAS, TX 75252 DEVICE: AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLEN CEREMED, INC. 510(k) NO: K080507(TRADITIONAL)
ATTN: TADEUSZ WELLISZ PHONE NO : 310-815-2125 3643 LENAWEE AVE. SE DECISION MADE: 21-APR-08 LOS ANGELES, CA 90016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO: SAVI APPLICATOR KIT CIANNA MEDICAL, INC. 510(k) NO: K080565(SPECIAL)
ATTN: GARY MOCNIK PHONE NO : 949-360-0059 6 JOURNEY SE DECISION MADE: 04-APR-08 SUITE 125 510(k) SUMMARY AVAILABLE FROM FDA ALISO VIEJO, CA 92656 DEVICE: SMARTSPOT PRIMAX CMT MEDICAL TECHNOLOGIES, LTD. 510(k) NO: K080890(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 4 8246632 6 SIRENI SE DECISION MADE: 29-APR-08 HAIFA, ISRAEL 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VF GEL COAPT SYSTEMS, INC. 510(k) NO: K080956(SPECIAL)
ATTN: LINDA RUEDY PHONE NO : 650-461-7647 1820 EMBARCADERO RD. SE DECISION MADE: 25-APR-08 PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BAHA CORDELLE II COCHLEAR BONE ANCHORED SYSTEMS AB 510(k) NO: K080363(TRADITIONAL)
ATTN: SEAN BUNDY PHONE NO : 303-790-9010 400 INVERNESS PARKWAY SE DECISION MADE: 10-APR-08 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA ENGLEWOOD, CO 80112 DEVICE: COMPUMEDICS SOMTE PSG RECORDING SYSTEM COMPUMEDICS LIMITED 510(k) NO: K072201(TRADITIONAL)
ATTN: GORDON FERGUSON PHONE NO : 61 3 84207300 30-40 FLOCKHART STREET SE DECISION MADE: 14-APR-08 ABBOTSFORD 510(k) SUMMARY AVAILABLE FROM FDA MELBOURNE, VICTORIA, AUSTRALIA 3067 DEVICE: CONMED LINVATEC OSPREY DRILL SYSTEM CONMED LINVATEC 510(k) NO: K080444(TRADITIONAL)
ATTN: SUE F DAUTERMAN PHONE NO : 727-399-5321 11311 CONCEPT BOULEVARD SE DECISION MADE: 02-APR-08 LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W COOK UROLOGICAL, INC. 510(k) NO: K080525(TRADITIONAL)
ATTN: CINDY FOOTE PHONE NO : 812-829-4891 750 DANIELS WAY SE DECISION MADE: 17-APR-08 BLOOMINGTON, IN 47404 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: FOUNDATION CAGE CORELINK LLC 510(k) NO: K073440(TRADITIONAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD SE DECISION MADE: 24-APR-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IGG ANTI-ATHEROX TEST KIT CORGENIX, INC. 510(k) NO: K072032(TRADITIONAL)
ATTN: DANIEL F SIMPSON PHONE NO : 303-457-4345 11575 MAIN ST. SE DECISION MADE: 04-APR-08 SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA BROOMFIELD, CO 80020 DEVICE: TETRIX CREAM CORIA LABORATORIES, LTD 510(k) NO: K071483(TRADITIONAL)
ATTN: AMY CAMPBELL PHONE NO : 817-900-4000 3909 HULEN ST SE DECISION MADE: 04-APR-08 FORTH WORTH, TX 76107 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CONVENIENCE KIT FOR "SINGLE-INCISION LAPAROSCOPIC SURGERY AND OT COVIDIEN 510(k) NO: K072814(TRADITIONAL)
ATTN: ROBERT ZOTT PHONE NO : 203-492-6013 60 MIDDLETOWN AVE. SE DECISION MADE: 16-APR-08 NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BIOMOVE 5000 SYSTEM CURATRONIC, LTD. 510(k) NO: K080787(SPECIAL)
ATTN: AHAVA STEIN PHONE NO : 972 976 70002 20 HATA ' AS ST. SE DECISION MADE: 17-APR-08 KFAR SABA, ISRAEL 44425 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) CUTERA, INC. 510(k) NO: K080300(TRADITIONAL)
ATTN: KATHY MAYNOR PHONE NO : 415-657-5586 3240 BAYSHORE BLVD SE DECISION MADE: 08-APR-08 BRISBANE, CA 94005 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TACAHE PC1350 POWER WHEELCHAIR DALTON MEDICAL CORP. 510(k) NO: K080373(TRADITIONAL)
ATTN: WILL RIDGWAY PHONE NO : 972-418-5129 1103 VENTURE CT. SE DECISION MADE: 14-APR-08 CARROLLTON, TX 75006 510(k) STATEMENT DEVICE: DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT DEMETECH CORP. 510(k) NO: K072930(TRADITIONAL)
ATTN: A.J. DIMERCURIO PHONE NO : 262-387-1610 3530 N.W. 115TH AVE. SE DECISION MADE: 30-APR-08 MIAMI, FL 33178 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAPPHIRE O/E ORAL EXAMINATION SYSTEM DEN-MAT HOLDINGS, LLC 510(k) NO: K073483(TRADITIONAL)
ATTN: ALAN MATTHEWS PHONE NO : 805-922-8491 2727 SKYWAY DR. SE DECISION MADE: 03-APR-08 SANTA MARIA, CA 93455 510(k) STATEMENT DEVICE: DENTIS DENTAL IMPLANT SYSTEM DENTIS CO. LTD. 510(k) NO: K073486(TRADITIONAL)
ATTN: CHANG DAE KYU PHONE NO : 562-404-8466 13340 E FIRESTONE BLVD SE DECISION MADE: 04-APR-08 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA SANTA FE SPRINGS, CA 90670 DEVICE: COMPOSITE ALIGNER BUTTON DENTSPLY INTERNTIONAL 510(k) NO: K080246(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511 221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 11-APR-08 SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17405 DEVICE: MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM DENTSPLY INTERNTIONAL 510(k) NO: K080311(TRADITIONAL)
ATTN: HELEN LEWIS PHONE NO : 717-849-7511 221 W. PHILADELPHIA ST. STE.60 SE DECISION MADE: 18-APR-08 SUSQUEHANNA COMMERCE CRT. WEST 510(k) SUMMARY AVAILABLE FROM FDA YORK, PA 17404 DEVICE: DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL DEPUY MITEK 510(k) NO: K080918(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-828-3359 325 PARAMOUNT DRIVE SE DECISION MADE: 23-APR-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EXPEDIUM 4.5MM SPINE SYSTEM DEPUY SPINE, INC. 510(k) NO: K073364(SPECIAL)
ATTN: CHRISTOPHER KLACZYK PHONE NO : 508-828-2852 325 PARAMOUNT DR. SE DECISION MADE: 04-APR-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. 510(k) NO: K080191(SPECIAL)
ATTN: FRANK S JURCZAK PHONE NO : 508-828-3288 325 PARAMOUNT DR. SE DECISION MADE: 02-APR-08 RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. 510(k) NO: K080315(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434 49 PLAIN ST. SE DECISION MADE: 23-APR-08 NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI DEXELA LTD 510(k) NO: K080351(TRADITIONAL)
ATTN: BARRY SALL PHONE NO : 781-434-4742 200 WEST STREET SE DECISION MADE: 22-APR-08 WALTHAM, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 DING HWA CO., LTD. 510(k) NO: K080005(TRADITIONAL)
ATTN: HUI-CHEN KAI PHONE NO : 886 3 3280026 NO. 6, LANE 29, WENMING RD. SE DECISION MADE: 24-APR-08 GUISHAN, TAOYUAN, CHINA (TAIWAN) 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DIO IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. 510(k) NO: K070570(TRADITIONAL)
ATTN: KENNY LIM PHONE NO : 562-404-8466 13340 E. FIRESTONE BLVD SE DECISION MADE: 15-APR-08 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA SANTA FE SPRINGS, CA 90670 DEVICE: DIO PROTEM IMPLANT SYSTEM DIO DEPARTMENT DSI, INC. 510(k) NO: K080126(TRADITIONAL)
ATTN: HYUNGICK KIM PHONE NO : 213-365-2875 3540 WILSHIRE BLVD. SE DECISION MADE: 11-APR-08 SUITE 1104 510(k) SUMMARY AVAILABLE FROM FDA LOS ANGELES, CA 90010 DEVICE: NACERA Z AND NACERA Z MEDIUM DOCERAM MEDICAL CERAMICS GMBH 510(k) NO: K080195(TRADITIONAL)
ATTN: HOLGER WAMPERS PHONE NO : 49 231 9256680 65-67 HESSLINGSWEG SE DECISION MADE: 28-APR-08 DORTMUND, NRW, GERMANY D-44309 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRANSPOSAL ULTRA SYSTEMS DORNOCH MEDICAL SYSTEMS, INC. 510(k) NO: K081047(TRADITIONAL)
ATTN: ANTHONY MARTINI PHONE NO : 888-466-3633 4032 WEST RIVERSIDE ST. SE DECISION MADE: 29-APR-08 RIVERSIDE, MO 64150 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 DRAEGER MEDICAL AG & CO. KG 510(k) NO: K072885(TRADITIONAL)
ATTN: KATHY ANDERSON PHONE NO : 215-660-2078 3135 QUARRY ROAD SE DECISION MADE: 07-APR-08 TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SMART-ROD DUOJECT MEDICAL SYSTEMS, INC. 510(k) NO: K070584(TRADITIONAL)
ATTN: CAROLINE LAVOIE PHONE NO : 450 534 3666 50 CHEMIN DE GASPE SE DECISION MADE: 02-APR-08 COMPLEX B-5 510(k) SUMMARY AVAILABLE FROM FDA BROMONT, CANADA J2L 2N8 DEVICE: ENDOWAVE INFUSION SYSTEM EKOS CORP. 510(k) NO: K073166(TRADITIONAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3132 11911 N CREEK PARKWAY SOUTH SE DECISION MADE: 22-APR-08 BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO ENDOWAVE INFUSION SYSTEM EKOS CORP. 510(k) NO: K080392(SPECIAL)
ATTN: JOCELYN KERSTEN PHONE NO : 425-415-3132 11911 N CREEK PARKWAY SOUTH SE DECISION MADE: 30-APR-08 BOTHELL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOW FLUID ALARM EM-TEC GMBH 510(k) NO: K080704(ABBREVIATED)
ATTN: BERNHARD BRAND PHONE NO : 49 880 692360 LERCHENBERG 20 SE DECISION MADE: 17-APR-08 FINNING, BAVARIA, GERMANY 86923 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: MODIFICATION TO ENDOFAST RELIANT SYSTEM ENDOGUN MEDICAL SYSTEMS 510(k) NO: K080836(SPECIAL)
ATTN: DORIT WINITZ PHONE NO : 972 3 6123281 JABOTINSKY STREET 7 SE DECISION MADE: 21-APR-08 RAMAT GAN, ISRAEL 52520 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER ENDOLOGIX, INC. 510(k) NO: K080360(SPECIAL)
ATTN: ANNALIZA VICTORIA PHONE NO : 949-595-7228 11 STUDEBAKER SE DECISION MADE: 08-APR-08 IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ENTELLUS MEDICAL RS-SERIES SYSTEM ENTELLUS MEDICAL, INC. 510(k) NO: K072302(TRADITIONAL)
ATTN: TOM RESSEMANN PHONE NO : 763-463-1592 10200 73RD. AVE. NORTH SE DECISION MADE: 08-APR-08 SUTIE 122 510(k) SUMMARY AVAILABLE FROM FDA MAPLE GROVE, MN 55369 DEVICE: ERBE VIO ESU, MODEL VIO 200 S ERBE USA, INC. 510(k) NO: K080715(SPECIAL)
ATTN: JOHN TARTAL PHONE NO : 770-955-4400 2225 NORTHWEST PKWY. SE DECISION MADE: 02-APR-08 MARIETTA, GA 30067 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ERCHONIA EML LASER ERCHONIA MEDICAL, INC. 510(k) NO: K072206(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412 13 RED FOX LANE SE DECISION MADE: 24-APR-08 LITTLETON, CO 80127 510(k) STATEMENT DEVICE: S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SC ESAOTE S.P.A. 510(k) NO: K080968(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500 11460 N. MERIDIAN ST. SE DECISION MADE: 29-APR-08 SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA CARMEL, IN 46032 DEVICE: CAP PLUS, EQUIVABONE, CAP/DBM ETEX CORP. 510(k) NO: K080329(TRADITIONAL)
ATTN: PAMELA W ADAMS PHONE NO : 617-577-7270 38 SIDNEY ST., 3FLR SE DECISION MADE: 28-APR-08 THE CLARK BLDG. 510(k) SUMMARY AVAILABLE FROM FDA CAMBRIDGE, MA 02139 DEVICE: FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 EUROPEAN CUSTOM MANUFACTURING BV 510(k) NO: K080621(TRADITIONAL)
ATTN: WILLIAM GREENROSE PHONE NO : 603-369-3550 220 RIVER ROAD SE DECISION MADE: 29-APR-08 CLAREMONT, NH 03743 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WG-SURGICAL SUTURES WITH NEEDLE FOOSIN MEDICAL SUPPLIES INC. 510(k) NO: K073614(TRADITIONAL)
ATTN: DIANA HONG PHONE NO : 862 164 264467 SUITE 8D, ZHONGXIN ZHONGSHAN SE DECISION MADE: 30-APR-08 MANSION, NO. 19 LANE 999 510(k) SUMMARY AVAILABLE FROM FDA ZHONG SHAN, SHANGHAI, CHINA 20030 DEVICE: MANUAL RIGID MOBILITY WHEELCHAIR FREEDOM DESIGNS, INC. 510(k) NO: K080270(TRADITIONAL)
ATTN: BOB GARDNER PHONE NO : 805-582-0077 2241 MADERA RD. SE DECISION MADE: 16-APR-08 SIMI VALLEY, CA 93065 510(k) STATEMENT DEVICE: FCR GO PORTABLE DIGITAL X-RAY SYSTEM FUJIFILM MEDICAL SYSTEMS U.S.A., I510(k) NO: K080945(TRADITIONAL)
ATTN: DEBBIE PEACOCK PHONE NO : 203-602-3774 419 WEST AVE. SE DECISION MADE: 18-APR-08 STAMFORD, CT 06902-6300 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PASSIVE WASTE GAS SCAVENGER, MODEL 14600 G. DUNDAS CO.,INC. 510(k) NO: K080039(TRADITIONAL)
ATTN: MARIO SORCI PHONE NO : 253-631-8008 24301 ROBERTS DR. SE DECISION MADE: 14-APR-08 BLACK DIAMOND, WA 98010 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNIFAST III GC AMERICA, INC. 510(k) NO: K073106(TRADITIONAL)
ATTN: MARK HEISS PHONE NO : 708-926-3105 3737 WEST 127TH ST. SE DECISION MADE: 11-APR-08 ALSIP, IL 60803 510(k) STATEMENT DEVICE: SIGNA 3.0T MR750 SYSTEM GE MEDICAL SYSTEMS, LLC 510(k) NO: K081028(TRADITIONAL)
ATTN: MARK STAUFFER PHONE NO : 262-521-6891 3200 N. GRANDVIEW BLVD. SE DECISION MADE: 25-APR-08 WAUKESHA, WI 53188 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER GLOBAL USA DISTRIBUTION, LLC. 510(k) NO: K080697(TRADITIONAL)
ATTN: RONALD BERGLUND PHONE NO : 952-220-3014 9220 JAMES AVENUE SOUTH SE DECISION MADE: 07-APR-08 MINNEAPOLIS, MN 55431 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GBI TSH NEONATAL SCREENING KIT GOLDEN BRIDGE INTERNATIONAL, INC. 510(k) NO: K072458(TRADITIONAL)
ATTN: XIAOPING ZHANG PHONE NO : 425-493-1801 9700 HARBOUR PL. SUITE 129 SE DECISION MADE: 10-APR-08 MUKILTEO, WA 98275 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES GRACE MEDICAL, INC. 510(k) NO: K080070(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000 8500 WOLF LAKE DR., STE. 110 SE DECISION MADE: 17-APR-08 MEMPHIS, TN 38133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SAFETY INFUSION SET GREINER BIO-ONE VACUETTE NORTH AME510(k) NO: K080235(TRADITIONAL)
ATTN: JUDITH SMITH PHONE NO : 410-592-2060 13801 ECK ROAD SE DECISION MADE: 24-APR-08 HYDES, MD 21082 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELLGRAFT PE II GWOWEI TECHNOLOGY CO., LTD. 510(k) NO: K072170(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340 2904 N. BOLDT DRIVE SE DECISION MADE: 04-APR-08 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WELLGRAFT PE I GWOWEI TECHNOLOGY CO., LTD. 510(k) NO: K072444(TRADITIONAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-6340 2904 N. BOLDT DRIVE SE DECISION MADE: 04-APR-08 FLAGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8 HANDAN HENGYONG PROTECTIVE & CLEAN510(k) NO: K080827(ABBREVIATED)
ATTN: MAGGIE ZHONG PHONE NO : 862 133 907930 1-1-1201, 455 GONGNONG ROAD SE DECISION MADE: 04-APR-08 SHIJIAZHUANG, HEBEI PROVINCE, CHIN510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50 HEEYOUNG CO., LTD. 510(k) NO: K073358(TRADITIONAL)
ATTN: CARL THOMAS PHONE NO : 940-300-8601 1600 MANCHESTER WAY SE DECISION MADE: 25-APR-08 CORINTH, TX 76210 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CUTTERSIL ACTIVATOR UNIVERSAL PLUS HERAEUS KULZER GMBH 510(k) NO: K080338(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6692 4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 21-APR-08 SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICAR HILL-ROM MANUFACTURING, INC. 510(k) NO: K080226(SPECIAL)
ATTN: DAWN M REILLY PHONE NO : 919-854-3361 1225 CRESCENT GREEN DR. SE DECISION MADE: 09-APR-08 SUITE 200 510(k) STATEMENT CARY, NC 27511 DEVICE: HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM HYPNOCORE, LTD. 510(k) NO: K073269(TRADITIONAL)
ATTN: GEORGE J HATTUB PHONE NO : 508-479-6116 291 HILLSIDE AVENUE SE DECISION MADE: 18-APR-08 SOMERSET, MA 02726 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IGROK IGROK, LLC 510(k) NO: K080325(TRADITIONAL)
ATTN: ROBERT J RIKER PHONE NO : 412-398-5841 234 GRAHAM ST., STE 200 SE DECISION MADE: 08-APR-08 SEWICKLEY, PA 15143 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 INFRAREDX, INC. 510(k) NO: K072932(TRADITIONAL)
ATTN: STEVEN J CHARTIER PHONE NO : 781-221-0053 34 THIRD AVE SE DECISION MADE: 25-APR-08 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MPS OXIPORT AND MPS OXIPORT PLUS INNERSPACE, INC. 510(k) NO: K072379(SPECIAL)
ATTN: DON BOBO PHONE NO : 949-752-8672 1622 EDINGER AVENUE, SUITE C SE DECISION MADE: 29-APR-08 TUSTIN, CA 92780 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IROOT SP INNOVATIVE BIOCERAMIX INC. 510(k) NO: K080917(TRADITIONAL)
ATTN: QUANZU YANG PHONE NO : 604 221 6800 1628 WEST 75TH AVE. SE DECISION MADE: 09-APR-08 VANCOUVER, BC, CANADA V6P 6G2 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM INTERLACE MEDICAL, INC. 510(k) NO: K073690(TRADITIONAL)
ATTN: RON ADAMS PHONE NO : 508-875-1343 139 NEWBURY STREET SE DECISION MADE: 17-APR-08 FRAMINGHAM, MA 01701 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IRSG I-MOVER FOR BEDS INTERNATIONAL RETAIL SERVICES GROU510(k) NO: K072598(TRADITIONAL)
ATTN: KAREN M RUSSELL PHONE NO : 425-398-1875 12230 NE WOODINVILLE DR. SE DECISION MADE: 14-APR-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA WOODINVILLE, WA 98072 DEVICE: INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 INTOUCH TECHNOLOGIES 510(k) NO: K073710(TRADITIONAL)
ATTN: BILL STOUT PHONE NO : 805-562-8686 90 CASTILIAN DRIVE SE DECISION MADE: 11-APR-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA GOLETA, CA 93117 DEVICE: IFS LASER SYSTEM INTRALASE CORP. 510(k) NO: K073404(TRADITIONAL)
ATTN: MAUREEN WEINER PHONE NO : 949-584-5771 5 GRINDLAY PL SE DECISION MADE: 25-APR-08 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 J. MORITA USA, INC. 510(k) NO: K073695(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K ST. N.W. SE DECISION MADE: 09-APR-08 SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: VERAVIEWEPOCS J. MORITA USA, INC. 510(k) NO: K073696(TRADITIONAL)
ATTN: KEITH A BARRITT PHONE NO : 202-783-5070 1425 K ST. N.W. SE DECISION MADE: 08-APR-08 SUITE 1100 510(k) SUMMARY AVAILABLE FROM FDA WASHINGTON, DC 20005 DEVICE: ELEGANCE WOMAN'S LUBRICANT JULIE WILLIAMS, PA-C 510(k) NO: K070587(TRADITIONAL)
ATTN: JULIE WILLIAMS PHONE NO : 512-294-1133 1209 ROBIN TRAIL SE DECISION MADE: 10-APR-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: K2M COCR ROD K2M, INC. 510(k) NO: K080792(SPECIAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155 751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 08-APR-08 LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K080410(TRADITIONAL)
ATTN: SUSIE CHEN PHONE NO : 310-338-8100 600 CORPORATE POINTE SE DECISION MADE: 09-APR-08 CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE KIMBERLY-CLARK CORP. 510(k) NO: K080821(SPECIAL)
ATTN: SHERRI SAURINI PHONE NO : 770-587-8502 1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 22-APR-08 ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MARIONETTE SA, MODEL 001 001 & 001 002 KINETIC SURGICAL LLC 510(k) NO: K072811(TRADITIONAL)
ATTN: JIM CAPUTO PHONE NO : 858-200-0439 6215 FERRIS SQUARE, SUITE 100 SE DECISION MADE: 21-APR-08 SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KOWA GENESIS-D KOWA CO. LTD. 510(k) NO: K080681(SPECIAL)
ATTN: SATOHIKO TAKANASHI PHONE NO : 81 356 238063 4-14, NIHONBASHI-HONCHO SE DECISION MADE: 04-APR-08 3-CHOME 510(k) SUMMARY AVAILABLE FROM FDA CHUO-KU, TOKYO, JAPAN 103-8433 DEVICE: KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIAT510(k) NO: K073590(TRADITIONAL)
ATTN: HEATHER VIELE PHONE NO : 208-377-4800 12554 WEST BRIDGER ST. SE DECISION MADE: 10-APR-08 SUITE 108 510(k) STATEMENT BOISE, ID 83713 DEVICE: LDR SPINE ROI-A IMPLANT LDR SPINE USA 510(k) NO: K080572(SPECIAL)
ATTN: NOAH BARTSCH PHONE NO : 512-344-3319 4030 WEST BRAKER LANE SE DECISION MADE: 07-APR-08 SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA AUSTIN, TX 78759 DEVICE: MODIFICATION TO:PILOT SPINAL SYSTEM LIFE SPINE 510(k) NO: K080502(SPECIAL)
ATTN: REBECCA M BROOKS PHONE NO : 847-884-6117 2401 W. HASSELL RD. SE DECISION MADE: 08-APR-08 SUITE 1535 510(k) SUMMARY AVAILABLE FROM FDA HOFFMAN ESTATES, IL 60169 DEVICE: PERIPHERAL NERVE BLOCK SUPPORT TRAY LIFE-TECH, INC. 510(k) NO: K073187(TRADITIONAL)
ATTN: JEFF KASOFF PHONE NO : 281-491-6600 4235 GREENBRIAR DR. SE DECISION MADE: 22-APR-08 STAFFORD, TX 77477-3995 510(k) STATEMENT DEVICE: LTM-T SURGICAL MESH LIFECELL CORP. 510(k) NO: K080353(TRADITIONAL)
ATTN: LORRAINE T MONTEMURRO PHONE NO : 908-947-1115 ONE MILLENNIUM WAY SE DECISION MADE: 03-APR-08 BRANCHBURG, NJ 08876 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. 510(k) NO: K073231(TRADITIONAL)
ATTN: KIM FONDA PHONE NO : 408-942-3733 1000 GIBRALTAR DR. SE DECISION MADE: 18-APR-08 MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOSTAT LIL DRUG STORE PRODUCTS, INC. 510(k) NO: K072414(TRADITIONAL)
ATTN: PATRICIA L MILLER PHONE NO : 319-294-3745 1201 CONTINENTAL PL. N.E. SE DECISION MADE: 07-APR-08 CEDAR RAPIDS, IA 52402 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECE LUTRONIC CORPORATION 510(k) NO: K080248(TRADITIONAL)
ATTN: MAUREEN O'CONNELL PHONE NO : 978-207-1245 5 TIMBER LANE SE DECISION MADE: 23-APR-08 NORTH READING, MA 01864 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT M.I.S. IMPLANTS TECHNOLOGIES LTD. 510(k) NO: K080162(TRADITIONAL)
ATTN: IMAN KHORSHID PHONE NO : 972 980 9966 P.O.B. 110 SE DECISION MADE: 22-APR-08 SHLOMI INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA SHLOMI, ISRAEL 22832 DEVICE: PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODE MAQUET CARDIOPULMONARY AG 510(k) NO: K072583(TRADITIONAL)
ATTN: KATRIN SCHWENKGLENKS PHONE NO : 011 497 4789210 HECHINGER STRASSE 38 SE DECISION MADE: 04-APR-08 HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION G MATANG MFG. SDN. BHD. 510(k) NO: K072614(TRADITIONAL)
ATTN: LESLIE LEONG PHONE NO : 606 263 3128 LOT 10, KAWASAN PERINDUSTRIAN SE DECISION MADE: 15-APR-08 SERKAM, MUKIM SERKAM 510(k) STATEMENT MERLIMAU, MELAKA, MALAYSIA 77300 DEVICE: SURGICASE MATERIALISE N.V. 510(k) NO: K073449(TRADITIONAL)
ATTN: MIEKE JANSSEN PHONE NO : 321 639 6611 15 TECHNOLOGIELAAN SE DECISION MADE: 16-APR-08 LEUVEN, BELGIUM 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MIMICS MATERIALISE N.V. 510(k) NO: K073468(TRADITIONAL)
ATTN: MIEKE JANSSEN PHONE NO : 32 16 396611 15 TECHNOLOGIELAAN SE DECISION MADE: 02-APR-08 LEUVEN, BELGIUM 3001 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION MEDACTA INTERNATIONAL, SA 510(k) NO: K080885(SPECIAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350 13721 VIA TRES VISTA SE DECISION MADE: 28-APR-08 SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MEDDORNA WIRELESS PRN SPIROMETER 100 MEDDORNA LLC 510(k) NO: K072722(TRADITIONAL)
ATTN: J. HARVEY KNAUSS PHONE NO : 713-723-4080 11874 SOUTH EVELYN CIRCLE SE DECISION MADE: 24-APR-08 HOUSTON, TX 77071 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HDL CHOLESTEROL REAGENT, MODEL 10211 MEDICA CORP. 510(k) NO: K073497(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892 5 OAK PARK DRIVE SE DECISION MADE: 14-APR-08 BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PASS SPINAL SYSTEM MEDICREA TECHNOLOGIES 510(k) NO: K080099(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199 1001 OAKWOOD BLVD. SE DECISION MADE: 09-APR-08 ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CORAMATE/SPIROTOME SYSTEM MEDINVENTS 510(k) NO: K080095(TRADITIONAL)
ATTN: JAAK JANSSENS PHONE NO : 321 127 1567 KLEIN HILLSTSTRAAT 5 SE DECISION MADE: 11-APR-08 HASSELT, LIMBURG, BELGIUM 3500 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. 510(k) NO: K080800(TRADITIONAL)
ATTN: SHIM KYUNG-AM PHONE NO : 82 2 21941381 1003, DAECHI-DONG SE DECISION MADE: 07-APR-08 GANGNAM-GU 510(k) SUMMARY AVAILABLE FROM FDA SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW DEVICE: LD-I 75 AND LD-I 200 MEDITECH INTERNATIONAL, INC. 510(k) NO: K072551(TRADITIONAL)
ATTN: RICHARD KEEN PHONE NO : 203-329-2700 1151 HOPE ST. SE DECISION MADE: 02-APR-08 STAMFORD, CT 06907 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING MEDLINE INDUSTRIES, INC. 510(k) NO: K071552(ABBREVIATED)
ATTN: MATT CLAUSEN PHONE NO : 847-643-4785 ONE MEDLINE PL. SE DECISION MADE: 25-APR-08 MUNDELEIN, IL 60060 510(k) STATEMENT DEVICE: QHRV 1 - HEALTH ASSESSMENT SYSTEM MEDTECHS, LLC 510(k) NO: K080884(TRADITIONAL)
ATTN: MEGHAN ATH PHONE NO : 919-619-7657 111 BEAVER DAM RUN SE DECISION MADE: 11-APR-08 DURHAN, NC 27703 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 MEDTRONIC MINIMED 510(k) NO: K073356(SPECIAL)
ATTN: MARK J FAILLACE PHONE NO : 818-576-5616 18000 DEVONSHIRE ST. SE DECISION MADE: 25-APR-08 NORTHRIDGE, CA 91325-1219 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTREPID SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K080083(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 10-APR-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK 510(k) NO: K080805(SPECIAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 18-APR-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K073291(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 24-APR-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. 510(k) NO: K080429(SPECIAL)
ATTN: LILA JOE PHONE NO : 901-396-3133 1800 PYRAMID PLACE SE DECISION MADE: 30-APR-08 MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RESCUE INTERNAL IMPLANT SYSTEM MEGAGEN CO., LTD. 510(k) NO: K073058(TRADITIONAL)
ATTN: STEVE CHANG PHONE NO : 562-404-8466 13340 E. FIRESTONE BLVD. SE DECISION MADE: 11-APR-08 SUITE J 510(k) SUMMARY AVAILABLE FROM FDA SANTA FE SPRINGS, CA 90670 DEVICE: NEXCOMP AND META ETCHANT META BIOMED CO., LTD. 510(k) NO: K080305(TRADITIONAL)
ATTN: TAE-HOON KIM PHONE NO : 82 43 2181983 414-12 MO CHOONG DONG SE DECISION MADE: 07-APR-08 CHEONG JU 510(k) SUMMARY AVAILABLE FROM FDA CHEUNG CITY, CHUNG BUK, REPUBLIC OF KOREA 441-12 DEVICE: SURGI GLOVES METACURE SURGICAL GLOVES SDN BHD 510(k) NO: K073447(TRADITIONAL)
ATTN: JEFRI SHARAAI PHONE NO : 603 778 12829 NO. 1, JLN 203, OFF JALAN SE DECISION MADE: 24-APR-08 TANDANG 510(k) SUMMARY AVAILABLE FROM FDA PETALING JAYA, MALAYSIA 46050 DEVICE: DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-32 MICRO INVASIVE TECHNOLOGY INC. 510(k) NO: K072613(TRADITIONAL)
ATTN: JOHN BALA PHONE NO : 860-779-6130 934 NORTH MAIN ST SE DECISION MADE: 21-APR-08 DANIELSON, CT 06239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TRAXCESS 0.014" HYDROPHILIC GUIDEWIRE MICROVENTION, INC. 510(k) NO: K080863(TRADITIONAL)
ATTN: KEVIN E DALY PHONE NO : 949-461-3314 75 COLUMBIA SE DECISION MADE: 17-APR-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA ALISO VIEJO, CA 92656-1408 THIRD PARTY REVIEW DEVICE: ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 MONOBIND, INC. 510(k) NO: K063437(TRADITIONAL)
ATTN: JAY SINGH PHONE NO : 949-951-2665 100 N. POINTE DR. SE DECISION MADE: 04-APR-08 LAKE FOREST, CA 92630 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TEM 3002G- HN DUAL TUNE HEAD COIL MR INSTRUMENTS, INC. 510(k) NO: K080820(TRADITIONAL)
ATTN: MARK WATSON PHONE NO : 952-746-1435 5610 ROWLAND ROAD SE DECISION MADE: 02-APR-08 SUITE 145 510(k) SUMMARY AVAILABLE FROM FDA MINNETONKA, MN 55343 THIRD PARTY REVIEW DEVICE: VARIOS 75 NAKANISHI, INC. 510(k) NO: K071447(TRADITIONAL)
ATTN: TOMOKO HIRABAYASHI PHONE NO : 028 964 3380 700 SHIMOHINATA SE DECISION MADE: 18-APR-08 KANUMA-SHI, TOCHIGI-KEN, JAPAN 322510(k) STATEMENT DEVICE: 3TEST SUPREME GLUCOSE MONITORING SYSTEM NEUERO ENGINEERING INC. 510(k) NO: K072905(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829 NO 58, FU-CHIUN STREET SE DECISION MADE: 18-APR-08 HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE NEURO RESOURCE GROUP, INC. 510(k) NO: K070217(TRADITIONAL)
ATTN: KRISTA OAKES PHONE NO : 972-665-1810 1100 JUPITER RD., STE. 190 SE DECISION MADE: 04-APR-08 PLANO, TX 75074 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: IMPULSE IQ ADJUSTING INSTRUMENT NEUROMECHANICAL INNOVATIONS, LLC 510(k) NO: K080261(TRADITIONAL)
ATTN: CHRISTOPHER J COLLOCA PHONE NO : 480-785-8442 11011 SOUTH 48TH ST., STE. 220 SE DECISION MADE: 11-APR-08 PHOENIX, AZ 85044 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NEURMETRIX ADVANCE NEUROMETRIX, INC. 510(k) NO: K070109(TRADITIONAL)
ATTN: RAINER N MAAS PHONE NO : 781-890-9989 62 FOURTH AVE. SE DECISION MADE: 25-APR-08 WALTHAM, MA 02451 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COOLTOUCH MODELS LC215 AND COOLLIPO NEW STAR LASERS, INC. 510(k) NO: K080163(TRADITIONAL) ATTN: NATALIE R VOLLRATH PHONE NO : 916-677-1900 9085 FOOTHILLS BLVD. SE DECISION MADE: 10-APR-08 ROSEVILLE, CA 95747 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RTM AND OVAL NEXT MOBILITY, LLC 510(k) NO: K080880(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-944-9320 543 LONG HILL AVENUE SE DECISION MADE: 09-APR-08 SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: PC ECG 1200W SYSTEM NORAV MEDICAL LTD. 510(k) NO: K080141(SPECIAL)
ATTN: BENNY ARAZY PHONE NO : 972 499 47880 INDUSTRIAL PARK 13 SE DECISION MADE: 25-APR-08 M.P. MISGAV 510(k) SUMMARY AVAILABLE FROM FDA MITZPE AVIV, ISRAEL 20187 DEVICE: MODEL D DISC FORCE NORTH AMERICAN MEDICAL CORP (NAM) 510(k) NO: K073132(TRADITIONAL)
ATTN: CHELLO GRACE PHONE NO : 770-541-0012 1649 SANDS PLACE S.E. SE DECISION MADE: 03-APR-08 SUITE A 510(k) SUMMARY AVAILABLE FROM FDA MARIETTA, GA 30067 THIRD PARTY REVIEW DEVICE: DENTAL UNIT WITH CHAIR NORTH WEST MEDICAL INSTRUMENT (GRO510(k) NO: K080438(TRADITIONAL)
ATTN: DIANE HONG PHONE NO : 86 21 64264468 # 19, LANE 999 ZHONGSHAN 2 RD SE DECISION MADE: 04-APR-08 SUITE 8D 510(k) SUMMARY AVAILABLE FROM FDA SHANGHAI, CHINA 200030 THIRD PARTY REVIEW DEVICE: TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE S NUCLETRON CORPORATION 510(k) NO: K080871(SPECIAL)
ATTN: LISA DIMMICK PHONE NO : 443-545-2196 8671 ROBERT FULTON DR. SE DECISION MADE: 29-APR-08 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ONCENTRA GYN NUCLETRON CORPORATION 510(k) NO: K080929(TRADITIONAL)
ATTN: LISA DIMMICK PHONE NO : 443-545-2196 8671 ROBERT FULTON DR. SE DECISION MADE: 16-APR-08 COLUMBIA, MD 21046-2133 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ONCOBIONIC SYSTEM ONCOBIONIC INCORPORATED 510(k) NO: K080376(TRADITIONAL)
ATTN: PAUL MIKUS PHONE NO : 949-888-6658 30211 AVENIDA DE LAS BANDERAS SE DECISION MADE: 02-APR-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA RANCHO SANTA MARGARITA, CA 92688 DEVICE: ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 OPTIM, INC. 510(k) NO: K080622(SPECIAL)
ATTN: ROBERT KRUPA PHONE NO : 508-347-5100 64 TECHNOLOGY PARK RD. SE DECISION MADE: 02-APR-08 STURBRIDGE, MA 01566-1262 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: US/GS ULTRA WIDE SYSTEM OSSTEM IMPLANT CO.,LTD 510(k) NO: K073465(TRADITIONAL)
ATTN: MIN JOO KIM PHONE NO : 215-738-2990 ONE BEN FAIRLESS DR. SE DECISION MADE: 07-APR-08 FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PLEXUR-P OSTEOTECH, INC. 510(k) NO: K080511(TRADITIONAL)
ATTN: CHRIS TALBOT PHONE NO : 732-542-2800 51 JAMES WAY SE DECISION MADE: 21-APR-08 EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHARAON LIPO OSYRIS 510(k) NO: K073617(TRADITIONAL)
ATTN: JAOUAD ZEMMOURI PHONE NO : 330 320 675997 121 RUE CHANZY, BP 90140 SE DECISION MADE: 09-APR-08 HELLEMMES , FRANCE, FRANCE F59260 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS OXLIFE LLC 510(k) NO: K080082(TRADITIONAL)
ATTN: MARGARET K POTEAT PHONE NO : 828-684-7353 141 TWIN SPRINGS RD. SE DECISION MADE: 16-APR-08 HENDERSONVILLE, NC 28792 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PALOMAR ASPIRE LASER PLATFORM PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K080567(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414 82 CAMBRIDGE ST. SE DECISION MADE: 16-APR-08 BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GENTRIS RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG N PARAGONDX, LLC 510(k) NO: K071867(TRADITIONAL)
ATTN: DEBORAH N KLOOS PHONE NO : 919-653-4748 133 SOUTHCENTER COURT SE DECISION MADE: 28-APR-08 SUITE 200 510(k) STATEMENT MORRISVILLE, NC 27560 DEVICE: PHILIPS ECG ALGORITHM PHILIPS MEDICAL SYSTEMS 510(k) NO: K073376(SPECIAL)
ATTN: PAUL SCHRADER PHONE NO : 978-659-2404 3000 MINUTEMAN RD. SE DECISION MADE: 11-APR-08 ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: BRIGHTVIEW VCT IMAGING SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K080927(TRADITIONAL)
ATTN: COLEEN A COLEMAN PHONE NO : 408-468-3051 540 ALDER DRIVE SE DECISION MADE: 11-APR-08 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: GEMINI CONDOR PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K081135(TRADITIONAL)
ATTN: MELINDA NOVATNY PHONE NO : 440-483-4255 595 MINER RD. SE DECISION MADE: 29-APR-08 CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: NM APPLICATION SUITE PHILIPS NUCLEAR MEDICINE, INC 510(k) NO: K080961(TRADITIONAL)
ATTN: LORI R PETERSON PHONE NO : 408-468-3042 540 ALDER DR. SE DECISION MADE: 18-APR-08 MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 POSSIS MEDICAL, INC. 510(k) NO: K080806(TRADITIONAL)
ATTN: MIKE BURNSIDE PHONE NO : 763-780-4555 9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 04-APR-08 MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A PROMEDICAL PRODUCTS CO., LTD. 510(k) NO: K080627(SPECIAL)
ATTN: LEO WEI PHONE NO : 86 519 88222111 # 206 HAUNG HE ROAD WEST SE DECISION MADE: 24-APR-08 CHANGZHOU, JIANGSU, CHINA 213022 510(k) STATEMENT DEVICE: FAST1 INTRAOSSEOUS INFUSION SYSTEM PYNG MEDICAL CORP. 510(k) NO: K080865(TRADITIONAL)
ATTN: MAYA BUTTERFIELD PHONE NO : 604 303 7964 #7-13511 CRESTWOOD PL SE DECISION MADE: 24-APR-08 RICHMOND, B.C., CANADA V6V 2E9 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL REGENERATION TECHNOLOGIES, INC. 510(k) NO: K080418(TRADITIONAL)
ATTN: TRAVIS AROLA PHONE NO : 386-418-8888 11621 RESEARCH CIR. SE DECISION MADE: 30-APR-08 P.O. BOX 2650 510(k) SUMMARY AVAILABLE FROM FDA ALACHUA, FL 32616-2650 DEVICE: S8 ESCAPE II RESMED LTD. 510(k) NO: K080079(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 08-APR-08 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VPAP ST RESMED LTD. 510(k) NO: K080131(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238 14040 DANIELSON ST. SE DECISION MADE: 01-APR-08 POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: COMFORTGEL FULL FACE MASK RESPIRONICS INC., SLEEP & HOME RES510(k) NO: K073600(TRADITIONAL)
ATTN: ZITA T YURKOS PHONE NO : 724-387-4120 1001 MURRY RIDGE LN. SE DECISION MADE: 25-APR-08 MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: RAMP INFLUENZA A/B ASSAY RESPONSE BIOMEDICAL CORP. 510(k) NO: K071591(TRADITIONAL)
ATTN: KEN PILGRIM PHONE NO : 604 456 6010 100 - 8900 GLENLYON PARKWAY SE DECISION MADE: 16-APR-08 BURNABY, BRITISH COLUMBIA, CANADA 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM ROCHE DIAGNOSTICS CORP. 510(k) NO: K072714(SPECIAL)
ATTN: THERESA A BUSH PHONE NO : 317-521-3723 9115 HAGUE RD. SE DECISION MADE: 18-APR-08 INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ISOBAR SEMI-RIGID DUAL DAMPENER SCIENT'X 510(k) NO: K071261(TRADITIONAL)
ATTN: JOHN SANDERS PHONE NO : 407-571-2550 1015 MAITLAND CENTER COMMONS SE DECISION MADE: 17-APR-08 SUITE 106A 510(k) SUMMARY AVAILABLE FROM FDA MAITLAND, FL 32751 DEVICE: SIERRA SEASPINE, INC. 510(k) NO: K072729(SPECIAL)
ATTN: ETHEL BERNAL PHONE NO : 760-727-8399 2302 LA MIRADA DR. SE DECISION MADE: 17-APR-08 VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SIERRA SYSTEM SEASPINE, INC. 510(k) NO: K080526(SPECIAL)
ATTN: ETHEL BERNAL PHONE NO : 760-727-8399 2302 LA MIRADA DR. SE DECISION MADE: 16-APR-08 VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SEDAT MYSHELL LITE SEDAT 510(k) NO: K080472(SPECIAL)
ATTN: LAETITIA COUSIN PHONE NO : 858-678-0569 8895 TOWNE CENTRE DRIVE SE DECISION MADE: 23-APR-08 105-416 510(k) SUMMARY AVAILABLE FROM FDA SAN DIEGO, CA DEVICE: BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202 SEJOY ELECTRONICS & INSTRUMENTS CO510(k) NO: K080789(TRADITIONAL)
ATTN: JIANYAO WU PHONE NO : 408-513-4006 6367 BANCROFT WAY SE DECISION MADE: 03-APR-08 SAN JOSE, CA 95129 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, SENORX, INC. 510(k) NO: K080791(TRADITIONAL)
ATTN: EBEN GORDON PHONE NO : 949-362-4800 11 COLUMBIA SE DECISION MADE: 30-APR-08 ALISO VIEJO, CA 92656 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K080192(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN PHONE NO : 949-429-5825 55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 03-APR-08 GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYME SIAM SEMPERMED CORP. LTD. 510(k) NO: K080520(ABBREVIATED)
ATTN: WILLIAM E HARRIS PHONE NO : 727-787-7250 13900 49TH STREET NORTH SE DECISION MADE: 30-APR-08 CLEARWATER, FL 33762 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNGO MULTIMODALITY WORKPLACE SIEMENS AG, MEDICAL SOLUTIONS 510(k) NO: K072728(TRADITIONAL)
ATTN: SABINE SCHROEDEL PHONE NO : 499 131 848285 HENKESTRASSE 127 SE DECISION MADE: 22-APR-08 ERLANGEN, GERMANY 91052 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: SYNGO DYNAMICS VERSION 7.0 SIEMENS MEDICAL SOLUTIONS 510(k) NO: K081018(SPECIAL)
ATTN: PHONE NO : 400 WEST MORGAN RD., SUITE 100 SE DECISION MADE: 25-APR-08 ANN ARBOR, MI 48108 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS SIEMENS MEDICAL SOLUTIONS DIAGNOST510(k) NO: K072658(TRADITIONAL)
ATTN: PHILIP LIU PHONE NO : 914-524-2443 511 BENEDICT AVENUE SE DECISION MADE: 01-APR-08 TARRYTOWN, NY 10591 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ACUSON X300 ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K080760(SPECIAL)
ATTN: MARTINA VOGT PHONE NO : 425-557-1434 1230 SHOREBIRD WAY SE DECISION MADE: 25-APR-08 MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TOSCA II ANTERIOR CERVICAL PLATE SYSTEM SIGNUS MEDIZINTECHNIK GMBH 510(k) NO: K080815(SPECIAL)
ATTN: KAREN E WARDEN PHONE NO : 440-729-8457 8202 SHERMAN ROAD SE DECISION MADE: 23-APR-08 CHSETERLAND, OH 44026 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CEREC OPTI SPRAY SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K080882(TRADITIONAL)
ATTN: PHONE NO : FABRIKSTRASSE 31 SE DECISION MADE: 11-APR-08 BENSHEIM, GERMANY D-64625 510(k) STATEMENT THIRD PARTY REVIEW DEVICE: PLLA, HA SCREW SMITH & NEPHEW INC., ENDOSCOPY DIV510(k) NO: K080358(TRADITIONAL)
ATTN: DEANA BOUSHELL PHONE NO : 508-337-4036 150 MINUTEMAN RD. SE DECISION MADE: 23-APR-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW SMITH & NEPHEW, INC. 510(k) NO: K080434(TRADITIONAL)
ATTN: ELIZABETH MILLER PHONE NO : 901-399-6176 1450 BROOKS RD. SE DECISION MADE: 10-APR-08 MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP SMITHS MEDICAL MD, INC. 510(k) NO: K080743(TRADITIONAL)
ATTN: DAVID H SHORT PHONE NO : 651-628-7240 1265 GREY FOX RD. SE DECISION MADE: 25-APR-08 ARDEN HILLS, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TURBO PRIME IBD SYSTEM SPINE SELECT, LLC 510(k) NO: K080058(TRADITIONAL)
ATTN: RICHARD JANSEN PHONE NO : 952-431-5999 13540 GUILD AVE SE DECISION MADE: 16-APR-08 APPLE VALLEY, MN 55124 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SPIRUS MEDICAL SURGICAL INSTRUMENT SPIRUS MEDICAL, INC. 510(k) NO: K080042(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552 5 WHITCOMB AVENUE SE DECISION MADE: 03-APR-08 AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DUREX PLAY SOFT & SENSUAL LUBRICANT SSL AMERICAS 510(k) NO: K071626(TRADITIONAL)
ATTN: CHRIS ROBINSON PHONE NO : 770-582-2174 3583 ENGINEERING DR. SUITE 200 SE DECISION MADE: 01-APR-08 NORCROSS, GA 30092 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CPS MOND TVOT STYLET, MODEL 4141, 4151, 4140, 4150 ST. JUDE MEDICAL, CARDIAC RHYTHM M510(k) NO: K080924(TRADITIONAL)
ATTN: COLLEEN CANAN PHONE NO : 818-493-2960 15900 VALLEY VIEW CT. SE DECISION MADE: 30-APR-08 SYLMAR, CA 91342 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMU-GRAPH EMULATOR, MODEL CI 131 STERITEC PRODUCTS MFG. CO., INC. 510(k) NO: K072408(TRADITIONAL)
ATTN: LINDA NELSON PHONE NO : 303-660-4201 599 TOPEKA WAY SE DECISION MADE: 30-APR-08 SUITE 400 510(k) STATEMENT CASTLE ROCK, CO 80109 DEVICE: P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS STRAUMANN MANUFACTURING, INC. 510(k) NO: K080239(TRADITIONAL)
ATTN: ELAINE ALAN PHONE NO : 978-747-2513 60 MINUTEMAN RD. SE DECISION MADE: 30-APR-08 ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS STRYKER SPINE 510(k) NO: K080928(SPECIAL)
ATTN: CURTIS TRUESDALE PHONE NO : 201-760-8296 2 PEARL COURT SE DECISION MADE: 30-APR-08 ALLENDALE, NJ 07401-1677 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PD SURGICAL SPECIALTIES CORP. 510(k) NO: K080985(SPECIAL)
ATTN: TRUDY D ESTRIDGE PHONE NO : 703-796-8927 13921 PARK CENTER RD. SE DECISION MADE: 23-APR-08 SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA HERNDON, VA 20171 DEVICE: ELTA ADVANCED WOUND WASH SWISS AMERICAN PRODUCTS, INC. 510(k) NO: K073610(TRADITIONAL)
ATTN: ERIC LUO PHONE NO : 972-385-2900 2055 LUNA RD., STE. 126 SE DECISION MADE: 23-APR-08 CARROLLTON, TX 75006 510(k) STATEMENT DEVICE: ELIPO SYNERON MEDICAL LTD. 510(k) NO: K073715(TRADITIONAL)
ATTN: YONI IGER PHONE NO : 972 73 2442200 P.O. BOX 550 SE DECISION MADE: 23-APR-08 INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA YOKNEAM ILLIT, ISRAEL 20692 DEVICE: ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODE SYNTHEON LLC 510(k) NO: K080317(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437 7290 SW 42ND ST. SE DECISION MADE: 29-APR-08 MIAMI, FL 33155 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES MATRIXMIDFACE PREFORMED ORBITAL PLATES SYNTHES (USA) 510(k) NO: K080331(TRADITIONAL)
ATTN: AMNON TALMOR PHONE NO : 610-719-6604 1302 WRIGHTS LANE EAST SE DECISION MADE: 30-APR-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS SYNTHES (USA) 510(k) NO: K080943(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940 1301 GOSHEN PKWY SE DECISION MADE: 23-APR-08 WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-30 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K073445(SPECIAL)
ATTN: ERICA LI PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 02-APR-08 WUGU TOWNSHIP 510(k) STATEMENT TAIPEI COUNTY, CHINA (TAIWAN) 248 DEVICE: CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -42 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K073494(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 02-APR-08 WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA TAIPEI COUNTY, CHINA (TAIWAN) 248 DEVICE: SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K080501(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 21-APR-08 WUGU TOWNSHIP 510(k) STATEMENT TAIPEI COUNTY, CHINA (TAIWAN) 241 DEVICE: FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116 TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K080593(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 2 66258188 6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 02-APR-08 WUGU TOWNSHIP 510(k) STATEMENT TAIPEI COUNTY, CHINA (TAIWAN) 248 DEVICE: COMPORUS TAKIRON CO., LTD 510(k) NO: K062691(TRADITIONAL)
ATTN: KENSHI OKAZAKI PHONE NO : 817 906 62411 405 NAGANO, YASUTOMI-CHO SE DECISION MADE: 15-APR-08 HIMEJI, JAPAN 671-2421 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL TCM WORLD INC. 510(k) NO: K071524(TRADITIONAL)
ATTN: YUWADEE IMTANAVANICH PHONE NO : 626-308-9233 1512 PROSPECT AVE. UNIT D SE DECISION MADE: 10-APR-08 SAN GABRIEL, CA 91776 510(k) STATEMENT DEVICE: CREATINE KINASE LIQUID REAGENT, MODEL C519-440 TECO DIAGNOSTICS 510(k) NO: K072548(TRADITIONAL)
ATTN: KELLY CHEN PHONE NO : 714-693-7788 1268 NORTH LAKEVIEW AVE. SE DECISION MADE: 18-APR-08 ANAHEIM, CA 92807 510(k) STATEMENT DEVICE: CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K080774(TRADITIONAL)
ATTN: GARRY A COURTNEY PHONE NO : 800-283-7866 125 BLUE BALL RD. SE DECISION MADE: 17-APR-08 ELKTON, MD 21921 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: THD DISPOSABLE ANOSCOPE/PROCTOSCOPE THD SPA 510(k) NO: K080132(TRADITIONAL)
ATTN: GUIDO BONAPACE PHONE NO : 39 051 6257315 VIA CALINDRI 50 SE DECISION MADE: 09-APR-08 S. LAZZARO DI SAVENA, BOLOGNA, ITA510(k) SUMMARY AVAILABLE FROM FDA DEVICE: EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIR THE ANSPACH EFFORT, INC. 510(k) NO: K080802(SPECIAL)
ATTN: JIM BANIC PHONE NO : 561-627-1080 4500 RIVERSIDE DR. SE DECISION MADE: 30-APR-08 PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM THEKEN SPINE LLC 510(k) NO: K080690(TRADITIONAL)
ATTN: DALE DAVISON PHONE NO : 330-475-8600 1800 TRIPLETT BLVD. SE DECISION MADE: 25-APR-08 AKRON, OH 44306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM THEKEN SPINE LLC 510(k) NO: K080790(SPECIAL)
ATTN: DALE DAVISON PHONE NO : 330-475-8600 1800 TRIPLETT BLVD. SE DECISION MADE: 29-APR-08 AKRON, OH 44306 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: GRAVILAX TRACTION SYSTEM THERAPEUTIC CLINICAL TECHNOLOGIES,510(k) NO: K072064(TRADITIONAL)
ATTN: DANIEL J MANELLI PHONE NO : 202-885-5548 5335 WISCONSIN AVE., SUITE 440 SE DECISION MADE: 21-APR-08 WASHINGTON, DC 20016 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MAS TOX CONTROL THERMO FISHER SCIENTIFIC 510(k) NO: K080085(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317-610-3823 46360 FREMONT BLVD. SE DECISION MADE: 30-APR-08 FREMONT, CA 94538 510(k) STATEMENT DEVICE: AMBULO 2400 TIBA MEDICAL, INC. 510(k) NO: K080274(TRADITIONAL)
ATTN: MERAT BAGHA PHONE NO : 503-222-1500 2701 N.W. VAUGHN ST. SE DECISION MADE: 23-APR-08 SUITE 470 510(k) SUMMARY AVAILABLE FROM FDA PORTLAND, OR 97210 DEVICE: TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM TORNIER, INC. 510(k) NO: K080335(TRADITIONAL)
ATTN: HOWARD SCHRAYER PHONE NO : 978-232-9997 100 CUMMINGS CENTER SE DECISION MADE: 23-APR-08 SUITE 444C 510(k) SUMMARY AVAILABLE FROM FDA BEVERLY, MA 01915 DEVICE: TRANS1 AXIALIF 2-LEVEL OR II SYSTEM TRANS1 INCORPORATED 510(k) NO: K073643(TRADITIONAL)
ATTN: ROBERT SHERIDAN PHONE NO : 910-509-0403 411 LANDMARK DR. SE DECISION MADE: 28-APR-08 WILMINGTON, NC 28412 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CENTURION SORBAVIEW OTC TRI-STATE HOSPITAL SUPPLY CORP. 510(k) NO: K080524(TRADITIONAL)
ATTN: MATTHEW K PRICE PHONE NO : 517-546-5400 301 CATRELL DR. SE DECISION MADE: 23-APR-08 HOWELL, MI 48843 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: KODAK 9000C EXTRAORAL IMAGING SYSTEM TROPHY 510(k) NO: K080889(SPECIAL)
ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 33 164 808500 4 RUE F. PELLOUTIER SE DECISION MADE: 29-APR-08 CROISSY-BEAUBOURG, FRANCE 77435 510(k) STATEMENT DEVICE: DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFIN TYSON BIORESEARCH, INC. 510(k) NO: K073492(TRADITIONAL)
ATTN: WEN-HAI TSAI PHONE NO : 886 375 85988 5 F., # 22, KE TUNG RD., SE DECISION MADE: 08-APR-08 SCIENCE BASED INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA CHUN-NAN, MIAO-LI COUNTY, CHINA (TAIWAN) 350 DEVICE: ULTRATEMP FIRM, FAST AND REGULAR SET ULTRADENT PRODUCTS, INC. 510(k) NO: K080768(SPECIAL)
ATTN: DIANE ROGERS PHONE NO : 801-553-4491 505 WEST 10200 SOUTH SE DECISION MADE: 11-APR-08 SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT. ULTRASPECT LTD. 510(k) NO: K080784(SPECIAL)
ATTN: DAN LAOR PHONE NO : 972 482 46632 6 SIRENI SE DECISION MADE: 02-APR-08 HAIFA, ISRAEL 32972 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, VASCULAR SOLUTIONS, INC. 510(k) NO: K073585(TRADITIONAL)
ATTN: ALYSSA MALINSKI PHONE NO : 763-656-4300 6464 SYCAMORE COURT SE DECISION MADE: 17-APR-08 MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PHYSIOFLOW SYSTEM VASOCOM, INC. 510(k) NO: K060387(TRADITIONAL)
ATTN: STEPHEN STAATS PHONE NO : 978-887-1408 2014 FORD RD., UNIT G SE DECISION MADE: 10-APR-08 BRISTOL, PA 19007 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DENTAL DIGITAL X-RAY IMAGING SYSTEM VATECH CO., LTD. 510(k) NO: K073365(TRADITIONAL)
ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059 30 NORTHPORT ROAD SE DECISION MADE: 08-APR-08 SOUND BEACH, NY 11789 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MODIFIED VERTIFLEX SPINAL SCREW SYSTEM VERTIFLEX, INC. 510(k) NO: K073143(TRADITIONAL)
ATTN: STEVE REITZLER PHONE NO : 949-940-1434 1351 CALLE AVANZADO SE DECISION MADE: 07-APR-08 SAN CLEMENTE, CA 92673 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY VIASYS HEALTHCARE GMBH 510(k) NO: K072061(TRADITIONAL)
ATTN: YVETTE LLOYD PHONE NO : 714-919-3247 22745 SAVI RANCH PKWY. SE DECISION MADE: 22-APR-08 YORBA LINDA, CA 92887 510(k) STATEMENT DEVICE: DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 VIEWORKS CO., LTD. 510(k) NO: K080553(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093 340 SHADY GROVE ROAD SE DECISION MADE: 16-APR-08 FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: TARGET STERILE ELECTRODE VISION QUEST INDUSTRIES, INC. 510(k) NO: K072799(TRADITIONAL)
ATTN: JAIME X PULLEY PHONE NO : 760-477-8201 18011 MITCHELL SO. SE DECISION MADE: 24-APR-08 IRVINE, CA 92614 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIVOSONIC NEUROSCREEN VIVOSONIC, INC. 510(k) NO: K080060(TRADITIONAL)
ATTN: AMJAD RANA PHONE NO : 416 231 9997 120-5525 EGLINTON AVENUE WEST SE DECISION MADE: 04-APR-08 TORONTO, ON, CANADA M9C 5K5 510(k) STATEMENT DEVICE: AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 WALLAC OY 510(k) NO: K070889(TRADITIONAL)
ATTN: GUNNEL LAAKSONEN PHONE NO : 358 2 2678357 MUSTIONKATU 6 SE DECISION MADE: 14-APR-08 TURKU, FINLAND 20750 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: WESTCON HORIZON 49% (HIOXIFILCON B) WESTCON CONTACT LENS CO. 510(k) NO: K080686(TRADITIONAL)
ATTN: KEVIN RANDALL PHONE NO : 303-828-0844 581 WHILES COURT SE DECISION MADE: 22-APR-08 ERIE, CO 80516-7225 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZENO PMMA DISC WIELAND DENTAL + TECHNIK GMBH & CO510(k) NO: K080182(TRADITIONAL)
ATTN: GERHARD POLZER PHONE NO : 490 723 13705219 SCHWENNINGER STRABE 13 SE DECISION MADE: 08-APR-08 PFORZHEIM, GERMANY D-75179 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: PROFEMUR LX REVISION 5/8 COATED HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K080663(SPECIAL)
ATTN: RYAN ROSS PHONE NO : 901-867-4401 5677 AIRLINE RD. SE DECISION MADE: 08-APR-08 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: DARCO HEADLESS COMPRESSION SCREW WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K080850(SPECIAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143 5677 AIRLINE RD. SE DECISION MADE: 10-APR-08 ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: YULEX LATEX POWDER-FREE EXAM GLOVES YULEX CORPORATION 510(k) NO: K063810(TRADITIONAL)
ATTN: KATRINA CORNISH PHONE NO : 520-381-2233 37860 W SMITH-ENKE RD SE DECISION MADE: 18-APR-08 MARICOPA, AZ 85239 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: VIZILITE EYEWEAR ZILA, INC. 510(k) NO: K080043(TRADITIONAL)
ATTN: MARK BRIDE PHONE NO : 602-266-6700 5227 N. 7TH ST. SE DECISION MADE: 04-APR-08 PHOENIX, AZ 85014 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CRYOMINI ZIMMER ELEKTROMEDIZIN GMBH 510(k) NO: K080735(SPECIAL)
ATTN: ARMIN PETRASCHKA PHONE NO : 490 731 97610 JUNKERSSTRASSE 9 SE DECISION MADE: 04-APR-08 NEU-ULM, GERMANY 89231 510(k) SUMMARY AVAILABLE FROM FDA THIRD PARTY REVIEW DEVICE: ZOLL E SERIES DEFIBRILLATOR ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K072923(TRADITIONAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386 269 MILL ROAD SE DECISION MADE: 24-APR-08 CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: ZOLL E SERIES 12SL, ANALYSIS OPTION ZOLL MEDICAL CORPORATION, WORLD WI510(k) NO: K080232(SPECIAL)
ATTN: EILEEN M BOYLE PHONE NO : 978-421-9171 269 MILL ROAD SE DECISION MADE: 23-APR-08 CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA TOTAL 510(k)s THIS PERIOD 257 TOTAL WITH SUMMARIES 228 TOTAL WITH STATEMENTS 29
Updated May 5, 2008
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