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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