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Medical Devices
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December 2008 510(k) Clearances
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-DEC-2008 THROUGH 31-DEC-2008
DEVICE: ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMA
MEDTRONIC INC. 510(k) NO: K080428(TRADITIONAL)
ATTN: MARLENE PETERSON PHONE NO : 763-526-2355
8200 CORAL SEA STREET NE SE DECISION MADE: 09-DEC-08
MOUNDS VIEW, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET
MEDTRONIC INC. 510(k) NO: K082670(SPECIAL)
ATTN: BETH CLAAS PHONE NO : 763-526-2384
8200 CORAL SEA STREET NE SE DECISION MADE: 04-DEC-08
MOUNDS VIEW, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
3M COMPANY 510(k) NO: K083610(TRADITIONAL)
ATTN: SCOTT ERICKSON PHONE NO : 651-736-9883
3M CENTER,BLDG. 275-2W-08 SE DECISION MADE: 17-DEC-08
ST. PAUL, MN 55144-1000 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: A-DEC 334/335 DELIVERY SYSTEM
A-DEC, INC. 510(k) NO: K082985(TRADITIONAL)
ATTN: THOMAS H LOUISELL PHONE NO : 503-538-9471
2601 CRESTVIEW DR. SE DECISION MADE: 17-DEC-08
NEWBERG, OR 97132-9257 510(k) STATEMENT
DEVICE: THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 900
ACCESS SCIENTIFIC, INC. 510(k) NO: K081697(TRADITIONAL)
ATTN: ALBERT MISAJON PHONE NO : 858-259-8333
12526 HIGH BLUFF DRIVE SE DECISION MADE: 04-DEC-08
SUITE 360 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: SURGISEAL TOPICAL SKIN ADHESIVE
ADHEZION BIOMEDICAL 510(k) NO: K082993(ABBREVIATED)
ATTN: RICHARD G JONES PHONE NO : 610-431-2398
506 PINE MOUNTAIN RD SE DECISION MADE: 19-DEC-08
HUDSON, NC 28638 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADIN DENTAL IMPLANTS SYSTEM
ADIN DENTAL IMPLANTS SYSTEM LTD 510(k) NO: K081751(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 499 40337
INDUSTRIAL PARK 13 SE DECISION MADE: 19-DEC-08
M.P. MISGAV 510(k) STATEMENT
MIZPE AVIV, ISRAEL 20187
DEVICE: E.COLI/P. AERUGINOSA PNA FISH
ADVANDX, INC. 510(k) NO: K081309(TRADITIONAL)
ATTN: HENRIK STENDER PHONE NO : 781-376-0009
10A ROESSLER ROAD SE DECISION MADE: 19-DEC-08
WOBURN, MA 01801 510(k) STATEMENT
DEVICE: INVISALIGN SYSTEM
ALIGN TECHNOLOGY 510(k) NO: K081960(TRADITIONAL)
ATTN: SANGEETA SACHDEVA PHONE NO : 408-470-1244
881 MARTIN AVE. SE DECISION MADE: 17-DEC-08
SANTA CLARA, CA 95050 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLOFUSE GEL AND PUTTY
ALLOSOURCE, INC. 510(k) NO: K071849(TRADITIONAL)
ATTN: PAMELA VETTER PHONE NO : 720-873-0213
6278 S. TROY CIRCLE SE DECISION MADE: 04-DEC-08
CENTENNIAL, CO 80111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
ALOKA CO., LTD. 510(k) NO: K083254(TRADITIONAL)
ATTN: RICHARD CEHOVSKY PHONE NO : 203-269-5088
10 FAIRFIELD BLVD. SE DECISION MADE: 19-DEC-08
WALLINGFORD, CT 06492 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ALPHA ORTHOPAEDICS AT2 SYSTEM
ALPHA ORTHOPAEDICS 510(k) NO: K082956(TRADITIONAL)
ATTN: GINA TO PHONE NO : 510-783-5888
23575 CABOT BLVD., STE. 2 SE DECISION MADE: 18-DEC-08
HAYWARD, CA 94545 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AMEDICA DRUG SCREEN TEST CUP
AMEDICA BIOTECH, INC. 510(k) NO: K082898(TRADITIONAL)
ATTN: JEFF CHEN PHONE NO : 510-785-5980
28301 INDUSTRIAL BLVD SUITE K SE DECISION MADE: 19-DEC-08
HAYWARD, CA 94545 510(k) STATEMENT
DEVICE: ABT GLUCOSE CONTROL SOLUTION
AMERICAN BIOLOGICAL TECHNOLOGIES, 510(k) NO: K083549(TRADITIONAL)
ATTN: JOHN GORMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD. SE DECISION MADE: 22-DEC-08
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PAR
AMERICAN MEDICAL SYSTEMS 510(k) NO: K082387(SPECIAL)
ATTN: SARAH PETERSON PHONE NO : 952-930-6431
10700 BREN ROAD WEST SE DECISION MADE: 04-DEC-08
MINNETONKA, MN 55416 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPR
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K082677(SPECIAL)
ATTN: MONA INMAN PHONE NO : 952-930-6204
10700 BREN RD., WEST SE DECISION MADE: 23-DEC-08
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440
ANGELUS INDUSTRIA DE PRODUCTOS ODO510(k) NO: K082180(TRADITIONAL)
ATTN: LINDA K SCHULZ PHONE NO : 858-792-1235
11234 EL CAMINO REAL, SE DECISION MADE: 17-DEC-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: RIMCLOSE BONE ANCHOR
ANULEX TECHNOLOGIES, INC 510(k) NO: K082729(TRADITIONAL)
ATTN: RACHEL KENNEDY PHONE NO : 952-224-4000
5600 ROWLAND ROAD, STE 280 SE DECISION MADE: 19-DEC-08
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-0
APOLLO ENDOSURGERY, INC. 510(k) NO: K082114(TRADITIONAL)
ATTN: DENNIS MCWILLIAMS PHONE NO : 512-328-9990
7000 BEE CAVES RD. SUITE 350 SE DECISION MADE: 19-DEC-08
AUSTIN, TX 78746 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIXATION TROCARS
APPLIED MEDICAL RESOURCES CORP. 510(k) NO: K083638(TRADITIONAL)
ATTN: PHONE NO :
22872 AVENIDA EMPRESA SE DECISION MADE: 23-DEC-08
RANCHO SANTA MARGARITA, CA 92688 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006
ARTEGRAFT, INC. 510(k) NO: K083370(SPECIAL)
ATTN: LAURENCE A POTTER PHONE NO : 732-422-8333
220 NORTH CENTER DR. SE DECISION MADE: 12-DEC-08
NORTH BRUNSWICK, NJ 08902 510(k) STATEMENT
DEVICE: ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHOND
ARTHREX, INC. 510(k) NO: K082999(TRADITIONAL)
ATTN: NANCY HOFT PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 30-DEC-08
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ARTHROCARE ARTHROWANDS
ARTHROCARE CORP. 510(k) NO: K083306(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 10-DEC-08
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TWIN NEUROTRAC-III
ASTRO-MED, INC. 510(k) NO: K081551(TRADITIONAL)
ATTN: ALFREDO BUSTAMANTE PHONE NO : 401-828-4000
600 EAST GREENWICH AVE. SE DECISION MADE: 24-DEC-08
WEST WARWICK, RI 02893 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMNI-TIGHT
BASIC DENTAL IMPLANT SYSTEMS, INC.510(k) NO: K082749(SPECIAL)
ATTN: DAN BLACKLOCK PHONE NO : 505-881-1376
3321 COLUMBIA N.E. SE DECISION MADE: 04-DEC-08
ALBUQUERQUE, NM 87107-2001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD GENEOHM CDIFF ASSAY
BD DIAGNOSTICS (GENEOHM SCIENCES, 510(k) NO: K081920(TRADITIONAL)
ATTN: RAYMOND BOULE PHONE NO : 858-334-6536
6146 NANCY RIDGE DR. SE DECISION MADE: 19-DEC-08
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
BECKMAN COULTER, INC. 510(k) NO: K081930(ABBREVIATED)
ATTN: LOURDES COBA PHONE NO : 305-380-4079
11800 SW 147TH AVE. SE DECISION MADE: 19-DEC-08
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
BECTON, DICKINSON & CO. 510(k) NO: K081824(TRADITIONAL)
ATTN: KATHRYN B CARR PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 11-DEC-08
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
BECTON, DICKINSON & CO. 510(k) NO: K081825(TRADITIONAL)
ATTN: KATHRYN B CARR PHONE NO : 410-316-4260
7 LOVETON CIR. SE DECISION MADE: 11-DEC-08
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-1
BECTON, DICKINSON & CO. 510(k) NO: K082913(TRADITIONAL)
ATTN: VICKI K WHITLEY PHONE NO : 410-316-4161
7 LOVETON CIR. SE DECISION MADE: 05-DEC-08
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM
BECTON, DICKINSON & CO. 510(k) NO: K083572(SPECIAL)
ATTN: DENNIS MERTZ PHONE NO : 410-316-4099
7 LOVETON CIR. SE DECISION MADE: 24-DEC-08
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY
BIO NUCLEAR DIAGNOSTICS, INC. 510(k) NO: K081522(TRADITIONAL)
ATTN: SURENDER CHOUDHRY PHONE NO : 416 674 1545
1791 ALBION RD. SE DECISION MADE: 05-DEC-08
TORONTO, ONTARIO, CANADA M9W 5S7 510(k) STATEMENT
DEVICE: SYSTEM-ARMS, MODELS 390, X60
BIO-MEDICAL RESEARCH, LTD. 510(k) NO: K083164(SPECIAL)
ATTN: ANNE-MARIE KEENAN PHONE NO : 353 91 774300
PARKMORE BUSINESS PARK, WEST SE DECISION MADE: 16-DEC-08
GALWAY, IRELAND 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205
BIOCOMFORT DIAGNOSTICS GMBH & CO. 510(k) NO: K081498(TRADITIONAL)
ATTN: MARTIN GABLER PHONE NO : 497 158 9801648
BERNHAEUSER STRASSE 17 SE DECISION MADE: 17-DEC-08
NEUHAUSEN A.D.F., GERMANY 73765 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
BIOCOMPATIBLES U.K. LIMITED 510(k) NO: K083091(TRADITIONAL)
ATTN: JOHN GREENBAUM PHONE NO : 954-680-2548
20310 SW 48TH STREET SE DECISION MADE: 24-DEC-08
FT. LAUDERDALE, FL 33332 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P
BIOKIT S.A. 510(k) NO: K082953(TRADITIONAL)
ATTN: JOAN GUIXER PHONE NO : 349 386 09000
CAN MALE S/N SE DECISION MADE: 22-DEC-08
LLICA D'AMUNT 510(k) SUMMARY AVAILABLE FROM FDA
BARCELONA, SPAIN 08186
DEVICE: EZLASE
BIOLASE TECHNOLOGY, INC. 510(k) NO: K082938(TRADITIONAL)
ATTN: IOANA RIZOIU PHONE NO : 949-226-8144
4 CROMWELL SE DECISION MADE: 22-DEC-08
IRVINE, CA 92618-1816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15W CERALAS D 1470NM DIODE LASER, MODEL D1470
BIOLITEC, INC. 510(k) NO: K082225(SPECIAL)
ATTN: JONATHAN S KAHAN PHONE NO : 202-637-5794
555 THIRTEENTH ST., NW SE DECISION MADE: 03-DEC-08
WASHINGTON, DC 20004-1109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIDAS RUB IGG
BIOMERIEUX, INC. 510(k) NO: K080766(TRADITIONAL)
ATTN: NIKITA S MAPP PHONE NO : 314-731-7474
595 ANGLUM RD. SE DECISION MADE: 23-DEC-08
HAZELWOOD, MO 63042 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOGGLELOC SYSTEM
BIOMET SPORTS MEDICINE 510(k) NO: K083070(TRADITIONAL)
ATTN: ROBERT FRIDDLE PHONE NO : 574-267-6639
P.O. BOX 587 SE DECISION MADE: 16-DEC-08
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIONET BM3PLUS PATIENT MONITOR
BIONET CO., LTD. 510(k) NO: K082008(TRADITIONAL)
ATTN: YINGCHAO XIAO PHONE NO : 626-799-0998
2600 MISSION ST., SUITE 100 SE DECISION MADE: 11-DEC-08
SAN MARINO, CA 91108 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPRO BIPOLAR HEAD, MODELS 18130-18152
BIOPRO, INC. 510(k) NO: K082705(TRADITIONAL)
ATTN: DAVID MRAK PHONE NO : 810-982-7777
17 SEVENTEENTH ST. SE DECISION MADE: 15-DEC-08
PORT HURON, MI 48060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISION WIRE CORONARY GUIDEWIRE
BIOTRONIK, INC. 510(k) NO: K082935(TRADITIONAL)
ATTN: JON BRUMBAUGH PHONE NO : 888-345-0374
6024 JEAN ROAD SE DECISION MADE: 04-DEC-08
LAKE OSWEGO, OR 97035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BITTAR ZIRCONIA BLOCKS
BITTAR ZIRCONIA BLOCK, LLC 510(k) NO: K082652(TRADITIONAL)
ATTN: STUART R GOLDMAN PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY SE DECISION MADE: 30-DEC-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML
BLAIREX LABORATORIES, INC. 510(k) NO: K083355(TRADITIONAL)
ATTN: CAREY BOTTOM PHONE NO : 812-378-1864
1600 BRIAN DR. SE DECISION MADE: 29-DEC-08
COLUMBUS, IN 47201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
BOSTON SCIENTIFIC CORP. 510(k) NO: K081739(TRADITIONAL)
ATTN: MARYBETH GAMBER PHONE NO : 508-683-4454
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 03-DEC-08
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BUSSE SURGICAL DRAPE
BUSSE HOSPITAL DISPOSABLES, INC. 510(k) NO: K082297(TRADITIONAL)
ATTN: MUHAMAD ANSARI PHONE NO : 631-435-4711
75 ARKAY DR. SE DECISION MADE: 09-DEC-08
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD PTFE (TEFLON) COATED GUIDE WIRES
C.R. BARD INC., BARD ELECTROPHYSIO510(k) NO: K082094(TRADITIONAL)
ATTN: DEBORAH L HERRINGTON PHONE NO : 978-323-2216
55 TECHNOLOGY DR. SE DECISION MADE: 17-DEC-08
LOWELL, MA 01851 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONQUEST PTA BALLOON DILATATION CATHETER
C.R. BARD, INC. 510(k) NO: K083657(TRADITIONAL)
ATTN: GENEVIEVE BALUTOWSKI PHONE NO : 480-303-2524
1625 WEST 3RD ST. SE DECISION MADE: 24-DEC-08
TEMPE, AZ 85281-1740 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS)
CANADA, INC. 510(k) NO: K081855(TRADITIONAL)
ATTN: FEDERICO FORERO PHONE NO : 770-912-4904
1100 HAMMOND DR. SE DECISION MADE: 19-DEC-08
SUITE 410A-223 510(k) SUMMARY AVAILABLE FROM FDA
ATLANTA, GA 30328
DEVICE: 9131 DEFIBRILLATION ELECTRODES
CARDIAC SCIENCE CORPORATION 510(k) NO: K082090(SPECIAL)
ATTN: BEVERLY MAGRANE PHONE NO : 425-402-2365
3303 MONTE VILLA PKWY. SE DECISION MADE: 12-DEC-08
BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT
CARDINAL HEALTH GERMANY 234 GMBH 510(k) NO: K082539(TRADITIONAL)
ATTN: THOMAS RUST PHONE NO : 499 314 972383
LEIBNIZSTRASSE 7 SE DECISION MADE: 02-DEC-08
HOECHBERG, BAVARIA, GERMANY 97204 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NICOLET CORTICAL STIMULATOR
CARDINAL HEALTH, INC. 510(k) NO: K072964(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 30-DEC-08
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARESTREAM PACS, MODEL CARESTREAM PACS VII
CARESTREAM HEALTH, INC. 510(k) NO: K083673(TRADITIONAL)
ATTN: LINDA STEWART PHONE NO : 585-627-6543
150 VERONA STREET SE DECISION MADE: 30-DEC-08
ROCHESTER, NY 14608 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS)
CARLETON LIFE SUPPORT SYSTEMS INC.510(k) NO: K082829(TRADITIONAL)
ATTN: GARY BYRD PHONE NO : 563-383-6299
2734 HICKORY GROVE RD. SE DECISION MADE: 22-DEC-08
DAVENPORT, IA 52804-1203 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
CASE MEDICAL, INC. 510(k) NO: K080558(TRADITIONAL)
ATTN: TANIA LUPU PHONE NO : 201-313-1999
65 RAILROAD AVE. SE DECISION MADE: 05-DEC-08
RIDGEFIELD, NJ 07657-0402 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
CELLAVISION AB 510(k) NO: K080595(TRADITIONAL)
ATTN: CONSTANCE G BUNDY PHONE NO : 763-574-1976
6740 RIVERVIEW TERRACE SE DECISION MADE: 05-DEC-08
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBOZENE MICROSPHERES
CELONOVA BIOSCIENCES, INC. 510(k) NO: K073417(TRADITIONAL)
ATTN: THOMAS A GORDY PHONE NO : 770-502-0304
49 SPRING ST. SE DECISION MADE: 15-DEC-08
NEWMAN, GA 30263 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHEETAH RELIANT
CHEETAH MEDICAL INC. 510(k) NO: K083093(ABBREVIATED)
ATTN: RHONA SHANKER PHONE NO : 301-251-9570
12154 DARNESTOWN RD. #236 SE DECISION MADE: 15-DEC-08
GAITHERSBURG, MD 20878 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
COOK INCORPORATED 510(k) NO: K081768(TRADITIONAL)
ATTN: SUSANNE GALIN PHONE NO : 812-339-2235
750 DANIELS WAY SE DECISION MADE: 23-DEC-08
BLOOMINGTON, IN 47404 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP)
CORE ESSENCE ORTHOPAEDICS, LLC 510(k) NO: K081060(ABBREVIATED)
ATTN: SHAWN T HUXEL PHONE NO : 215-310-9534
301 OXFORD VALLEY RD. SE DECISION MADE: 24-DEC-08
SUITE 905B 510(k) SUMMARY AVAILABLE FROM FDA
YARDLEY, PA 19067
DEVICE: CORFLO ANTI IV ENTERAL FEEDING TUBE
CORPAK MEDSYSTEMS 510(k) NO: K083210(TRADITIONAL)
ATTN: STEPHANIE WASIELEWSKI PHONE NO : 847-403-3484
100 CHADDICK DR. SE DECISION MADE: 29-DEC-08
WHEELING, IL 60090 510(k) STATEMENT
DEVICE: CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE
CYNOSURE, INC. 510(k) NO: K083379(SPECIAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
5 CARLISLE ROAD SE DECISION MADE: 12-DEC-08
WESTFORD, MA 01886 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ML24000 UVA-1 PHOTOTHERAPY CABINET
DAAVLIN DISTRIBUTING CO. 510(k) NO: K082731(TRADITIONAL)
ATTN: TARA MANSUR PHONE NO : 419-636-6304
205 WEST BEMENT ST. SE DECISION MADE: 17-DEC-08
BRYAN, OH 43506 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOBEAM 940, MODEL 940-900-02
DAVARAY, INC. 510(k) NO: K073681(TRADITIONAL)
ATTN: DAVID J ARNDT PHONE NO : 734-945-2510
2232 SOUTH MAIN STREET SE DECISION MADE: 09-DEC-08
SUITE 422 510(k) SUMMARY AVAILABLE FROM FDA
ANN ARBOR, MI 48103
DEVICE: CUSTOM COMFORT NIGHTGUARD
DENTEK ORAL CARE, INC. 510(k) NO: K083400(SPECIAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH STREET, NW SE DECISION MADE: 11-DEC-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LEDEX, MODEL: WL-070
DENTMATE TECHNOLOGY CO., LTD. 510(k) NO: K082408(TRADITIONAL)
ATTN: CHENG-FENG CHOU PHONE NO : 886 282 871812
NO. 80-1, LANE 160, SEC. 4 SE DECISION MADE: 03-DEC-08
SANHE ROAD 510(k) STATEMENT
SANCHUNG, CHINA (TAIWAN) 241
DEVICE: 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 22
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K082643(SPECIAL)
ATTN: ZHENG LIU PHONE NO : 508-977-3966
325 PARAMOUNT DR. SE DECISION MADE: 19-DEC-08
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY ASPHERE M-SPEC HEAD
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K082585(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 04-DEC-08
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY GLOBAL AP CTA HUMERAL HEAD
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K082715(SPECIAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 18-DEC-08
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-13121113
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K083364(SPECIAL)
ATTN: SUZANA OTANO PHONE NO : 305-269-6386
700 ORTHOPAEDIC DR. SE DECISION MADE: 11-DEC-08
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K081746(TRADITIONAL)
ATTN: GAIL R GOODRUM PHONE NO : 740-589-3300
1055 EAST STATE STREET SE DECISION MADE: 23-DEC-08
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ATHENS, OH 45701
DEVICE: D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
DIAGNOSTIC HYBRIDS, INC. 510(k) NO: K081928(TRADITIONAL)
ATTN: GAIL R GOODRUM PHONE NO : 740-589-3300
1055 EAST STATE STREET SE DECISION MADE: 23-DEC-08
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ATHENS, OH 45701
DEVICE: STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
DIAGNOSTICA STAGO, INC. 510(k) NO: K082248(TRADITIONAL)
ATTN: UMBERTO V PARROTTA PHONE NO : 973-631-1200
5 CENTURY DR. SE DECISION MADE: 12-DEC-08
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
DIASORIN, INC. 510(k) NO: K082049(TRADITIONAL)
ATTN: CAROL A DEPOUW PHONE NO : 651-351-5850
1951 NORTHWESTERN AVE. SE DECISION MADE: 05-DEC-08
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082-0285
DEVICE: ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) F
DIASYS DIAGNOSTICS SYSTEMS GMBH 510(k) NO: K080485(TRADITIONAL)
ATTN: STEPHANIE KLEIN PHONE NO : 49 643 29146151
ALTE STRASSE 9 SE DECISION MADE: 04-DEC-08
HOLZHEIM, RHEINLAND-PFALZ, GERMANY510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B
DIAZYME LABORATORIES 510(k) NO: K082001(SPECIAL)
ATTN: ABHIJIT DATTA PHONE NO : 858-455-4762
12889 GREGG COURT SE DECISION MADE: 05-DEC-08
POWAY, CA 92064 510(k) STATEMENT
DEVICE: STASYS MOTION CORRECTION SOFTWARE
DIGIRAD CORP. 510(k) NO: K082904(TRADITIONAL)
ATTN: JOEL TUCKEY PHONE NO : 858-726-1600
13950 STOWE DRIVE SE DECISION MADE: 17-DEC-08
POWAY, CA 92064-8803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVITE XL
DRAEGER MEDICAL AG & CO. KG 510(k) NO: K083050(SPECIAL)
ATTN: JOYCE KILROY PHONE NO : 215-660-2626
3135 QUARRY ROAD SE DECISION MADE: 29-DEC-08
TELFORD, PA 18969 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTSUITE HEMODYNAMICS 7.10
EMAGEON INC. 510(k) NO: K082421(TRADITIONAL)
ATTN: PHONE NO :
900 WALNUT RIDGE DRIVE SE DECISION MADE: 17-DEC-08
HARTLAND, WI 53029 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
EMSOMA CO., LTD. 510(k) NO: K083555(TRADITIONAL)
ATTN: WEONBUM LEE PHONE NO : 822 339 73970
#302 KANG-RIM B/D,SUNGNAE-DONG SE DECISION MADE: 16-DEC-08
448-7, GANGDONG-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 134-030 THIRD PARTY REVIEW
DEVICE: VIKY
ENDOCONTROL 510(k) NO: K082233(TRADITIONAL)
ATTN: CARINE HUGUEL PHONE NO : 33 476 637583
5 AVENUE DU GRAND SABLON SE DECISION MADE: 18-DEC-08
LA TRONCHE, FRANCE 38700 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VICARDIO 12B
ENERGY-LAB TECHNOLOGIES GMBH 510(k) NO: K082380(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 SE DECISION MADE: 03-DEC-08
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ERBE MODEL VIO 300 D WITH ACCESSORIES
ERBE USA, INC. 510(k) NO: K083452(SPECIAL)
ATTN: JULIE STEPHENS PHONE NO : 678-513-0693
111 LAUREL RIDGE DRIVE SE DECISION MADE: 31-DEC-08
ALPHARETTA, GA 30004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRAGER SHELL
ESI, INC. 510(k) NO: K082893(TRADITIONAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 05-DEC-08
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
ETHICON ENDO-SUGERY, LLC 510(k) NO: K082278(TRADITIONAL)
ATTN: CAROL HUBBARD PHONE NO : 513-337-3792
4545 CREEK RD. SE DECISION MADE: 16-DEC-08
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOCORSS .014 OTW PTA DILATATION CATHETER
EV3 INC. 510(k) NO: K082854(TRADITIONAL)
ATTN: DAVID WORRELL PHONE NO : 763-398-7344
4600 NATHAN LN. NORTH SE DECISION MADE: 04-DEC-08
PLYMOUTH, MN 55442-2920 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVATION 12/14 CEMENTED FEMORAL STEMS
EXACTECH, INC. 510(k) NO: K083392(SPECIAL)
ATTN: GRAHAM L CUTHBERT PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 17-DEC-08
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
EXCELSIOR MEDICAL CORP. 510(k) NO: K082837(SPECIAL)
ATTN: JOHN LINFANTE PHONE NO : 732-776-7525
1933 HECK AVE. SE DECISION MADE: 18-DEC-08
NEPTUNE, NJ 07753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LUBRICANO STERILE GEL
FARCO PHARMA GMBH 510(k) NO: K081990(TRADITIONAL)
ATTN: SETH A MAILHOT PHONE NO : 202-637-2309
555 ELEVENTH STREET NW SE DECISION MADE: 05-DEC-08
WASHINGTON, DC 20004-1304 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RUGALIFT, MODEL# V.2.1
FATROTEK S.R.L. 510(k) NO: K071573(ABBREVIATED)
ATTN: FRANSICO PELUSO PHONE NO : 39 089 3055.911
ROUTE DE LA GARE, 36 SE DECISION MADE: 09-DEC-08
AUVERNIER, SWITZERLAND 2012 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS
FLUKE BIOMEDICAL 510(k) NO: K083347(TRADITIONAL)
ATTN: COLLEEN BOSWELL PHONE NO : 714-516-7484
1717 WEST COLLINS AVE. SE DECISION MADE: 24-DEC-08
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FRESENIUS STERILE STAY SAFE CAP
FRESENIUS MEDICAL CARE NORTH AMERI510(k) NO: K083542(TRADITIONAL)
ATTN: JANET KAY PHONE NO : 781-699-4475
920 WINTER STREET SE DECISION MADE: 29-DEC-08
WALTHAM, MA 02451-1457 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GE DISCOVERY NM/CT 570C
GE MEDICAL SYSTEMS F.I. HAIFA 510(k) NO: K083504(TRADITIONAL)
ATTN: LAURENCE BIGIO PHONE NO : 972 485 63633
4 HAYOZMA ST. SE DECISION MADE: 12-DEC-08
TIRAT HACARMEL, ISRAEL 30200 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GENADYNE A4 WOUND VACUUM SYSTEM
GENADYNE BIOTECHNOLOGIES, INC. 510(k) NO: K082676(TRADITIONAL)
ATTN: CHIEN-MING GOH PHONE NO : 516-487-8787
65 WATERMILL LANE SE DECISION MADE: 18-DEC-08
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30
GENZYME DIAGNOSTICS P.E.I. INC. 510(k) NO: K082210(TRADITIONAL)
ATTN: PENNY J WHITE PHONE NO : 902 566 1396
700 WATTS AVENUE SE DECISION MADE: 16-DEC-08
CHARLOTTETOWN, PRIN ED ISLAND, CAN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SKINCLEAR Q-SWITCHED ND:YAG LASER
GLOBAL USA DISTRIBUTION, LLC. 510(k) NO: K083272(TRADITIONAL)
ATTN: MATT MAKOUSKY PHONE NO : 952-703-5373
10723 AQUILA AV. S. SE DECISION MADE: 16-DEC-08
MINNEAPOLIS, MN 55438 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: MODIFICATION TO:MICROFUSE BONE VOID FILLER
GLOBUS MEDICAL INC. 510(k) NO: K083232(TRADITIONAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
2560 GENERAL ARMISTEAD AVE. SE DECISION MADE: 24-DEC-08
AUDUBON, PA 19403 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPAR
GREINER BIO-ONE NORTH AMERICA, INC510(k) NO: K081929(SPECIAL)
ATTN: JUDI SMITH PHONE NO : 410-592-2060
P.O. BOX 103 SE DECISION MADE: 16-DEC-08
BALDWIN, MD 21013 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGG
GYRUS ACMI, INC. 510(k) NO: K083013(TRADITIONAL)
ATTN: GRAHAM A.L. BAILLIE PHONE NO : 508-804-2738
136 TURNPIKE RD. SE DECISION MADE: 09-DEC-08
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLEXITIME BITE
HERAEUS KULZER, INC., DENTAL PRODU510(k) NO: K082591(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 05-DEC-08
SOUTH BEND, IN 46614-2517 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BON
HITACHI MEDICAL SYSTEMS AMERICA, I510(k) NO: K083086(TRADITIONAL)
ATTN: DOUG THISTLETHWAITE PHONE NO : 330-425-1313
1959 SUMMIT COMMERCE PARK SE DECISION MADE: 05-DEC-08
TWINSBURG, OH 44087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TORNADO ROTATABEL SNARE AND POLYP CATCHER
HORIZONS INTL. CORP. 510(k) NO: K083049(TRADITIONAL)
ATTN: RAFIC SALEH PHONE NO : 506 226 19114
P.O. BOX 213-3006 SE DECISION MADE: 23-DEC-08
ZONA FRANCA METRO 510(k) STATEMENT
BARREAL DE HEREDIA, COSTA RICA
DEVICE: PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
HOSPIRA, INC. 510(k) NO: K081412(TRADITIONAL)
ATTN: DANIELA WEKSLER PHONE NO : 224-212-5316
275 NORTH FIELD DR. SE DECISION MADE: 17-DEC-08
D-389, BLDG., H2 510(k) SUMMARY AVAILABLE FROM FDA
LAKE FOREST, IL 60045 THIRD PARTY REVIEW
DEVICE: REJUVENATE MONOLITHIC HIP SYSTEM
HOWMEDICA OSTEONICS CORP 510(k) NO: K082892(TRADITIONAL)
ATTN: DENISE DAUGERT PHONE NO : 201-831-5413
325 CORPORATE DR. SE DECISION MADE: 29-DEC-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO T2 RECON NAIL SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K083437(SPECIAL)
ATTN: AVITAL MERL-MARGULIES PHONE NO : 201-831-6365
325 CORPORATE DRIVE SE DECISION MADE: 18-DEC-08
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IKOENGELO, VERSION 2
IKOETECH, LLC. 510(k) NO: K083591(SPECIAL)
ATTN: HUIMIN CHAO PHONE NO : 713-600-2410
6223 RICHMOND AVE., SUITE 303 SE DECISION MADE: 29-DEC-08
HOUSTON, TX 77057 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
IMPACT INSTRUMENTATION, INC. 510(k) NO: K071526(TRADITIONAL)
ATTN: LESLIE H SHERMAN PHONE NO : 973-882-1212
27 FAIRFIELD PL. SE DECISION MADE: 10-DEC-08
P.O. BOX 508 510(k) SUMMARY AVAILABLE FROM FDA
WEST CALDWELL, NJ 07006-0508
DEVICE: NEURO III-SV
IMRIS, INC. 510(k) NO: K083137(TRADITIONAL)
ATTN: THOMAS M TSAKERIS PHONE NO : 301-330-2076
16809 BRIARDALE ROAD SE DECISION MADE: 16-DEC-08
ROCKVILLE, MD 20855 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENVISION BLOOD GLUCOSE TEST SYSTEM
INFOPIA CO., LTD 510(k) NO: K082020(TRADITIONAL)
ATTN: MARIA F GRIFFIN PHONE NO : 704-516-8197
55 NORTHERN BLVD. SE DECISION MADE: 24-DEC-08
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200
INNOCHIPS TECHNOLOGY CO., LTD. 510(k) NO: K081788(TRADITIONAL)
ATTN: BRANDON CHOI PHONE NO : 714-523-1592
49 CANDLEWOOD WAY SE DECISION MADE: 17-DEC-08
BUENA PARK, CA 90621 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAV-LOK BUNION CORRECTION SYSTEM
INSTRATEK, INC. 510(k) NO: K082384(TRADITIONAL)
ATTN: JEFF SEAVEY PHONE NO : 281-890-8020
210 SPRINGHILL DR. SE DECISION MADE: 08-DEC-08
SUITE 130 510(k) SUMMARY AVAILABLE FROM FDA
SPRING, TX 77386
DEVICE: HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
INSTRUMENTATION LABORATORY CO. 510(k) NO: K082859(TRADITIONAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 19-DEC-08
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTEGRA MESHED BILAYER WOUND MATRIX
INTEGRA LIFESCIENCES CORP. 510(k) NO: K081635(TRADITIONAL)
ATTN: DIANA M BORDON PHONE NO : 609-936-2240
311 ENTERPRISE DR. SE DECISION MADE: 04-DEC-08
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT
INTERVENTIONAL SPINE, INC. 510(k) NO: K082795(TRADITIONAL)
ATTN: CAROL EMERSON PHONE NO : 949-472-0006
13700 ALTON PKWY., SUITE 160 SE DECISION MADE: 12-DEC-08
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WIT
INTUITIVE SURGICAL, INC. 510(k) NO: K081207(TRADITIONAL)
ATTN: JERRY TSUTSUMI PHONE NO : 408-523-2415
1266 KIFER ROAD SE DECISION MADE: 19-DEC-08
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IBA PROTON THERAPY SYSTEM- PROTEUS 235
ION BEAM APPLICATIONS S.A. 510(k) NO: K082416(TRADITIONAL)
ATTN: JOHN REISS PHONE NO : 215-972-7777
1500 MARKET STREET SE DECISION MADE: 12-DEC-08
CENTRE SQUARE WEST, 38TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
PHILADELPHIA, PA 19102
DEVICE: IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II
IVIVI TECHNOLOGIES, INC. 510(k) NO: K070541(TRADITIONAL)
ATTN: ANDRE DIMINO PHONE NO : 201-767-6040
224 PEGASUS AVE. SE DECISION MADE: 11-DEC-08
NORTHVALE, NJ 07647 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SMOOTHCOOL HR SYSTEM
JEISYS MEDICAL, INC. 510(k) NO: K082911(TRADITIONAL)
ATTN: KEVIN WALLS PHONE NO : 720-962-5412
5401 S. COTTONWOOD CT. SE DECISION MADE: 19-DEC-08
GREENWOOD VILLAGE, CO 80121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISTRAX
JOHN W. KING 510(k) NO: K080542(TRADITIONAL)
ATTN: EMILY B ROSSITER PHONE NO : 800-966-9376
800 EAST LEIGH STREET SE DECISION MADE: 15-DEC-08
SUITE 206-5 510(k) SUMMARY AVAILABLE FROM FDA
RICHMOND, VA 23219
DEVICE: MESA AND RANGE SPINAL SYSTEMS
K2M, INC. 510(k) NO: K082769(SPECIAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 11-DEC-08
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENON-100 SCB LIGHT SOURCE, MODEL 20132620
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K082925(TRADITIONAL)
ATTN: MONIKA CAMPBELL PHONE NO : 310-338-8100
600 CORPORATE POINTE DRIVE SE DECISION MADE: 18-DEC-08
CULVER CITY, CA 90230 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EOS SPINAL SYSTEM
KOREA BONE BANK CO., LTD 510(k) NO: K082509(TRADITIONAL)
ATTN: JUNG BAE BANG PHONE NO : 562-404-8466
13340 E. FIRESTONE BLVD. SE DECISION MADE: 15-DEC-08
SUITE J 510(k) SUMMARY AVAILABLE FROM FDA
SANTA FE SPRINGS, CA 90670
DEVICE: FREEWAY AND RAILRUNNER GUIDEWIRES
LAKE REGION MFG., INC. 510(k) NO: K082922(SPECIAL)
ATTN: DEEP PAL PHONE NO : 952-448-5111
340 LAKE HAZELTINE DR. SE DECISION MADE: 09-DEC-08
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYMPHONY METER REMOTE
LIFESCAN, INC. 510(k) NO: K082590(TRADITIONAL)
ATTN: MARTHA MURARI PHONE NO : 408-942-3703
1000 GIBRALTAR DR. SE DECISION MADE: 17-DEC-08
MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X
LIGHTHOUSE TECHNICAL INNOVATIONS, 510(k) NO: K083560(TRADITIONAL)
ATTN: JEAN ASQUITH PHONE NO : 512-327-9997
1705 S. CAPITAL OF TEXAS HWY. SE DECISION MADE: 11-DEC-08
SUITE 500 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746 THIRD PARTY REVIEW
DEVICE: BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR B
LIN-ZHI INTERNATIONAL, INC. 510(k) NO: K081008(TRADITIONAL)
ATTN: MARIE LIN PHONE NO : 408-732-3856
687 NORTH PASTORIA AVE. SE DECISION MADE: 22-DEC-08
SUNNYVALE, CA 94085-2917 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIPOSE FAT TRANSFER SYSTEM
LIPOSE CORP. 510(k) NO: K081848(TRADITIONAL)
ATTN: ALAN CURTIS PHONE NO : 925-209-7174
2647 LIN GATE COURT SE DECISION MADE: 04-DEC-08
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CENEFOM PVA SURGICAL SPEAR
LONGTEK SCIENTIFIC CO., LTD. 510(k) NO: K082460(TRADITIONAL)
ATTN: JOSEPH J CHANG PHONE NO : 832-545-8399
7128 STAFFORDSHIRE ST. SE DECISION MADE: 15-DEC-08
HOUSTON, TX 77030 510(k) STATEMENT
DEVICE: ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
LUMENIS, INC. 510(k) NO: K082809(TRADITIONAL)
ATTN: FRANCES E HARRISON PHONE NO : 770-630-3281
3959 WEST 1820 SOUTH SE DECISION MADE: 18-DEC-08
SALT LAKE CITY, UT 84104 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTROL CF PANEL I CONTROL, MODEL: G106
MAINE MOLECULAR QUALITY CONTROLS, 510(k) NO: K083171(TRADITIONAL)
ATTN: JOAN GORDON PHONE NO : 207-885-1072
10 SOUTHGATE ROAD SE DECISION MADE: 16-DEC-08
SUITE 170 510(k) SUMMARY AVAILABLE FROM FDA
SCARBOROUGH, ME 04074
DEVICE: TEMPORARY COLD.V AND SELF-CURE DENTINE
MAJOR PRODOTTI DENTARI S.P.A. 510(k) NO: K082700(ABBREVIATED)
ATTN: MONICA FUNAI PHONE NO : 39 011 6400211
VIA LUIGI EINAUDI 23 SE DECISION MADE: 09-DEC-08
MONACALIERI (TORINO), ITALY I-1002510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GRAFTGUARD PRESSURE CONTROLLING SYRINGE
MAQUET CARDIOVASCULAR, LLC 510(k) NO: K082725(TRADITIONAL)
ATTN: CHRISTINA L ROWE PHONE NO : 408-635-6824
170 BAYTECH DRIVE SE DECISION MADE: 17-DEC-08
SAN JOSE, CA 95134 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUBCUTANEOUS NEEDLE INFUSION SET
MARCAL MEDICAL, INC. 510(k) NO: K082818(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 23-DEC-08
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STE
MEDACTA INTERNATIONAL, SA 510(k) NO: K082792(SPECIAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 29-DEC-08
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDEGEN PRESSURE RATED EXTENSION SETS
MEDEGEN INC. 510(k) NO: K083472(TRADITIONAL)
ATTN: TIM L TRUITT PHONE NO : 909-390-9080
930 WANAMAKER AVE. SE DECISION MADE: 09-DEC-08
ONTARIO, CA 91761-8151 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL
MEDEGEN MEDICAL MANUFACTURING SERV510(k) NO: K083765(TRADITIONAL)
ATTN: MATTHEW FRIED PHONE NO : 909-390-9080
930 WANAMAKER AVE. SE DECISION MADE: 30-DEC-08
ONTARIO, CA 91761 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC
MEDICA CORP. 510(k) NO: K080810(TRADITIONAL)
ATTN: PHOTIOS MAKRIS PHONE NO : 781-275-4892
5 OAK PARK DRIVE SE DECISION MADE: 10-DEC-08
BEDFORD, MA 01730 510(k) STATEMENT
DEVICE: VIROCULT, MODEL MW950
MEDICAL WIRE & EQUIPMENT COMPANY (510(k) NO: K082472(ABBREVIATED)
ATTN: DAVID ELLIS PHONE NO : 441 225 810361
POTLEY LANE SE DECISION MADE: 30-DEC-08
CORSHAM, WILTSHIRE, UNITED KINGDOM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PASS LP SPINAL SYSTEM
MEDICREA TECHNOLOGIES 510(k) NO: K083308(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 10-DEC-08
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH
MEDICULT A/S 510(k) NO: K080172(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM.CHIRIMOLLA SE DECISION MADE: 18-DEC-08
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOFLEX LD-R100 TREATMENT HEAD
MEDITECH INTERNATIONAL, INC. 510(k) NO: K081355(ABBREVIATED)
ATTN: FRED KAHN PHONE NO : 416 251 1055
411 HORNER AVE., UNIT #1 SE DECISION MADE: 18-DEC-08
TORONTO, ONTARIO, CANADA M8W 4W3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLYDESDALE SPINAL SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K083026(TRADITIONAL)
ATTN: LEE GRANT PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 29-DEC-08
MEMPHIS, TN 38132-3576 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE
MEGADYNE MEDICAL PRODUCTS, INC. 510(k) NO: K080741(TRADITIONAL)
ATTN: RONDA K MAGNESON PHONE NO : 801-576-9669
11506 SOUTH STATE ST. SE DECISION MADE: 16-DEC-08
DRAPER, UT 84020 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIS INTERFACE FOR VITALOGIK PATIENT MONITORS
MENNEN MEDICAL LTD. 510(k) NO: K083063(TRADITIONAL)
ATTN: IFAT OREN PHONE NO : 972 8 9323333
4 HAYARDEN ST., YAVNE SE DECISION MADE: 16-DEC-08
P.O.BOX 102 510(k) SUMMARY AVAILABLE FROM FDA
REHOVOT, ISRAEL 76100
DEVICE: LAPEX BCS
MERIDIAN CO., LTD. 510(k) NO: K081962(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 29-DEC-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERIT MICROCATHETER
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K082613(TRADITIONAL)
ATTN: MICHAELA RIVKOWICH PHONE NO : 801-208-4196
1600 WEST MERIT PKWY. SE DECISION MADE: 30-DEC-08
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MISER CONTRAST MANAGEMENT SYSTEM
MERIT MEDICAL SYSTEMS, INC. 510(k) NO: K083576(SPECIAL)
ATTN: STEPHANIE ERSKINE PHONE NO : 801-208-4272
1600 WEST MERIT PKWY. SE DECISION MADE: 23-DEC-08
SOUTH JORDAN, UT 84095 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHAPERON GUIDING CATHETER
MICROVENTION, INC. 510(k) NO: K082385(TRADITIONAL)
ATTN: FLORIN TRUUVERT PHONE NO : 949-461-3314
75 COLUMBIA SE DECISION MADE: 11-DEC-08
ALISO VIEJO, CA 92656-1408 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEADWAY 17 MICROCATHETER
MICROVENTION, INC. 510(k) NO: K083343(TRADITIONAL)
ATTN: PHONE NO :
75 COLUMBIA SE DECISION MADE: 04-DEC-08
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
ALISO VIEJO, CA 92656-1408 THIRD PARTY REVIEW
DEVICE: MICROWARE BONE PLATES AND BONE SCREWS
MICROWARE PRECISION CO., LTD. 510(k) NO: K072562(TRADITIONAL)
ATTN: HARRISON DU PHONE NO : 886 4 24636275
NO. 12 KEYUAN 2ND RD. SE DECISION MADE: 04-DEC-08
SITUN DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG CITY, CHINA (TAIWAN) 40763
DEVICE: MODIFICATION TO MINISPIR, SPIROLAB III
MIR MEDICAL INTL. RESEARCH SRL 510(k) NO: K082766(SPECIAL)
ATTN: SIMON FOWLER PHONE NO : 39 062 2754777
VIA DEL MAGGIOLINO 125 SE DECISION MADE: 17-DEC-08
ROMA, ITALY 00155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIS CREST WIDENER
MIS - IMPLANT TECHNOLOGIES LTD. 510(k) NO: K080458(TRADITIONAL)
ATTN: IMAN KHORSHID PHONE NO : 972 498 09966
POB 110 SE DECISION MADE: 17-DEC-08
SHLOMI INDUSTRIAL ZONE 510(k) SUMMARY AVAILABLE FROM FDA
SHLOMI, ISRAEL 22832
DEVICE: MORTARA ELI 350 ELECTROCARDIOGRAPH
MORTARA INSTRUMENT, INC. 510(k) NO: K082946(TRADITIONAL)
ATTN: CHARLES MORREALE PHONE NO : 414-354-1600
7865 NORTH 86TH ST. SE DECISION MADE: 29-DEC-08
MILWAUKEE, WI 53224 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-0
NCONTACT SURGICAL, INC. 510(k) NO: K082203(SPECIAL)
ATTN: JANE RICUPERO PHONE NO : 919-655-1355
1001 AVIATION PARKWAY, SE DECISION MADE: 30-DEC-08
SUITE 400 510(k) SUMMARY AVAILABLE FROM FDA
MORRISVILLE, NC 27560
DEVICE: NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1
NEURONETICS 510(k) NO: K083538(SPECIAL)
ATTN: JUDY P WAYS PHONE NO : 610-640-4202
ONE GREAT VALLEY PKWY. SE DECISION MADE: 16-DEC-08
STE.2 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: FROG
NEWBY-COOMBS, LLC 510(k) NO: K072831(TRADITIONAL)
ATTN: KARLA COOMBS PHONE NO : 973-383-2121
21 UNION TURNPIKE SE DECISION MADE: 12-DEC-08
BRANCHVILLE, NJ 07826 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
NEWPORT MEDICAL INSTRUMENTS, INC. 510(k) NO: K082724(TRADITIONAL)
ATTN: DIANA RODRIGUEZ PHONE NO : 714-427-5811
1620 SUNFLOWER AVE. SE DECISION MADE: 16-DEC-08
COSTA MESA, CA 92626 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARK 5 NUVO LITE OCSI AND STD
NIDEK MEDICAL PRODUCTS, INC. 510(k) NO: K082566(ABBREVIATED)
ATTN: JENNIFER MCWILLIAMS PHONE NO : 205-856-7200
3949 VALLEY EAST INDUSTRIAL DR SE DECISION MADE: 03-DEC-08
BIRMINGHAM, AL 35217 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MO
NIHON KOHDEN AMERICA, INC. 510(k) NO: K083271(SPECIAL)
ATTN: JACK COGGAN PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 24-DEC-08
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION
NITRITEX (M) SDN. BHD. 510(k) NO: K081971(TRADITIONAL)
ATTN: DEREK WATTS PHONE NO : 603 312 22614
KEBUN BARU, JLN MASJID SE DECISION MADE: 23-DEC-08
TELOK PANGLIMA GARANG 510(k) SUMMARY AVAILABLE FROM FDA
KUALA LANGAT, SELANGOR DE, MALAYSIA 42500
DEVICE: BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
NITRITEX (M) SDN. BHD. 510(k) NO: K081972(TRADITIONAL)
ATTN: DEREK WATTS PHONE NO : 603 312 22614
KEBUN BARU, JLN MASJID SE DECISION MADE: 11-DEC-08
TELOK PANGLIMA GARANG 510(k) STATEMENT
KUALA LANGAT, SELANGOR DE, MALAYSIA 42500
DEVICE: NOVEON MODEL LS1100-03
NOMIR MEDICAL TECHNOLOGIES, INC. 510(k) NO: K083476(SPECIAL)
ATTN: RICHARD F BURTT PHONE NO : 781-893-1000
307 WAVERLEY OAKS ROAD SE DECISION MADE: 22-DEC-08
SUITE 109 510(k) SUMMARY AVAILABLE FROM FDA
WALTHAM, MA 02452
DEVICE: HOLTER LX ANALYSIS
NORTH EAST MONITORING INC. 510(k) NO: K081861(TRADITIONAL)
ATTN: JOSEPH AZARY PHONE NO : 203-922-0105
80 SHELTON TECHNOLOGY CENTER SE DECISION MADE: 04-DEC-08
SHELTON, CT 06484 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
NOVABONE PRODUCTS, LLC 510(k) NO: K082672(SPECIAL)
ATTN: DAVID M GALSSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 09-DEC-08
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEVONI CLASSIC, MODEL 6600-PO
NSR COMERCIO E REPRESENTACOES LTDA510(k) NO: K082878(ABBREVIATED)
ATTN: POLLY SCHERMAN PHONE NO : 781-856-4216
11 PERRY DRIVE UNIT G SE DECISION MADE: 30-DEC-08
FOXBORO, MA 02035 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: WOUND FLUSH, STERILE WATER & NORMAL SALINE
NURSE ASSIST, INC. 510(k) NO: K083042(TRADITIONAL)
ATTN: DENICE GALLAGHER PHONE NO : 972-446-6611
1415 HALSEY WAY, SUITE 304 SE DECISION MADE: 18-DEC-08
CARROLLTON, TX 75007-4455 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSCOPIC CO2 REGULATION UNIT UCR
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K081173(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 23-DEC-08
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM
OMNISONICS MEDICAL TECHNOLOGIES 510(k) NO: K083335(SPECIAL)
ATTN: ANNE M KULIS PHONE NO : 978-657-9980
66 CONCORD STREET, SUITE A SE DECISION MADE: 15-DEC-08
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATOR
ORTHO-CLINICAL DIAGNOSTICS 510(k) NO: K083173(SPECIAL)
ATTN: LEAH VAN DE WATER PHONE NO : 585-453-4131
100 INDIGO CREEK DRIVE MC881 SE DECISION MADE: 22-DEC-08
ROCHESTER, NY 14626-5101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MAXTORQUE MINI CANNULATED SCREW SYSTEM
ORTHOHELIX SURGICAL DESIGNS, INC. 510(k) NO: K082574(SPECIAL)
ATTN: DEREK LEWIS PHONE NO : 330-869-9562
1815 W. MARKET ST. SE DECISION MADE: 08-DEC-08
SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA
AKRON, OH 44313
DEVICE: STARBAND
ORTHOMERICA PRODUCTS, INC. 510(k) NO: K082950(TRADITIONAL)
ATTN: ALAN T SANDIFER PHONE NO : 407-290-6592
6333 NORTH ORANGE BLOSSOM SE DECISION MADE: 05-DEC-08
TRAIL 510(k) SUMMARY AVAILABLE FROM FDA
ORLANDO, FL 32810
DEVICE: ZIOCERA & CONVERTIBLE SYSTEM
OSSTEM IMPLANT CO LTD 510(k) NO: K081786(TRADITIONAL)
ATTN: MINJOO KIM PHONE NO : 267-759-7044
85 BEN FAIRLESS DR. SE DECISION MADE: 02-DEC-08
FAIRLESS HILLS, PA 19030 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEATER BASE, MODEL PMH7000
PACIFIC MEDICO CO., LTD. 510(k) NO: K080149(TRADITIONAL)
ATTN: YOSHIMO TOYAMA PHONE NO : 813 381 86127
2-6-4HONGO, BUNKYO-KU, SE DECISION MADE: 18-DEC-08
TOKYO, JAPAN 113-0033 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
PAUSCH LLC 510(k) NO: K081073(TRADITIONAL)
ATTN: JUSTIN TICE PHONE NO : 732-747-6110
808 SHREWSBURY AVENUE SE DECISION MADE: 05-DEC-08
TINTON FALLS, NJ 07724-3002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE
PEAK SURGICAL, INC. 510(k) NO: K082786(TRADITIONAL)
ATTN: GRACE CARLSON PHONE NO : 415-518-7043
2464 EMBARCADERO WAY SE DECISION MADE: 03-DEC-08
PALO ALTO, CA 94303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
PHILIPS MEDICAL SYSTEMS 510(k) NO: K083413(SPECIAL)
ATTN: TERESA SCHMIDT PHONE NO : 978-659-2220
3000 MINUTEMAN RD. SE DECISION MADE: 18-DEC-08
ANDOVER, MA 01810-1099 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PHILIPS MODEL MX 16 SLICE CT SYSTEM
PHILIPS MEDICAL SYSTEMS(CLEVELAND)510(k) NO: K083498(TRADITIONAL)
ATTN: MICHAEL CHILBERT PHONE NO : 440-483-3284
595 MINER RD. SE DECISION MADE: 17-DEC-08
CLEVELAND, OH 44143 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC
POLYVUE DISTRIBUTION, INC. 510(k) NO: K080794(TRADITIONAL)
ATTN: GAROLD L EDWARDS PHONE NO : 408-221-3860
7077 MCADAMS LANE SE DECISION MADE: 17-DEC-08
FELTON, CA 95018 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
POSSIS MEDICAL, INC. 510(k) NO: K082382(TRADITIONAL)
ATTN: MARK STENOIEN PHONE NO : 763-780-4555
9055 EVERGREEN BLVD., N.W. SE DECISION MADE: 12-DEC-08
MINNEAPOLIS, MN 55433-8003 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH R
POWER MEDICAL INTERVENTIONS, INC. 510(k) NO: K083527(SPECIAL)
ATTN: BARBARA J WHITMAN PHONE NO : 267-775-8151
2021 CABOT BLVD. SE DECISION MADE: 18-DEC-08
LANGHORNE, PA 19047 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELI
PT. MEDISAFE TECHNOLOGIES 510(k) NO: K082302(TRADITIONAL)
ATTN: ANIL TANEJA PHONE NO : 626 130 007134
JL.BATANG KUIS GG.TAMBAK REJO SE DECISION MADE: 09-DEC-08
DESA BUNTU BEDIMBAR TJ. MORAWA 510(k) STATEMENT
MEDAN, NORTH SUMATERA, INDONESIA 20362
DEVICE: POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
QUALITY GALLANT SDN. BHD. 510(k) NO: K081592(TRADITIONAL)
ATTN: SEAH BEE HOON PHONE NO : 605 849 4931
LOT 1874, JALAN KAMPUNG DEW SE DECISION MADE: 03-DEC-08
SIMPANG HALT 510(k) STATEMENT
TAIPING, PERAK, MALAYSIA 34700
DEVICE: QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY
QUANTA SYSTEM, S.P.A. 510(k) NO: K083613(TRADITIONAL)
ATTN: ISABELLA CARRER PHONE NO : 390 331 376797
VIA IV NOVEMBRE,116 SE DECISION MADE: 23-DEC-08
SOLBIATE OLONA(VA), ITALY 21058 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: PROLITE III TOWER AND PR AND HR HANDPIECE
QUANTEL S.A. 510(k) NO: K081095(TRADITIONAL)
ATTN: MICHAEL JOHNSON PHONE NO : 406-586-0131
601 HAGGERTY LANE SE DECISION MADE: 12-DEC-08
BOZEMAN, MT 59715 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MO
QUANTRX BIOMEDICAL CORPORATION 510(k) NO: K080455(TRADITIONAL)
ATTN: NATALIE J KENNEL PHONE NO : 858-705-0350
13721 VIA TRES VISTA SE DECISION MADE: 31-DEC-08
SAN DIEGO, CA 92129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THROMBO TEK PSE, MODEL 90-480
R2 DIAGNOSTICS, INC. 510(k) NO: K082631(TRADITIONAL)
ATTN: MARC D GOLDFORD PHONE NO : 574-288-4377
1801 COMMERCE DR. SE DECISION MADE: 17-DEC-08
SOUTH BEND, IN 46628 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
RALCO S.R.L. 510(k) NO: K083029(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-378-8858
P.O. BOX 7007 SE DECISION MADE: 05-DEC-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REGEN COLLAGEN SCAFFOLD (CS)
REGEN BIOLOGICS, INC. 510(k) NO: K082079(TRADITIONAL)
ATTN: JOHN DICHIARA PHONE NO : 201-651-3505
411 HACKENSACK AVENUE SE DECISION MADE: 18-DEC-08
HACKENSACK, NJ 07601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIMIRA OCS 3000
REMICALM, LLC 510(k) NO: K082603(TRADITIONAL)
ATTN: DAVID B JONES PHONE NO : 713-984-8550
952 ECHO LANE, SUITE 333 SE DECISION MADE: 12-DEC-08
HOUSTON, TX 77024-2758 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED
RICH MOUNTAIN MEDICAL PRODUCTS, IN510(k) NO: K082448(TRADITIONAL)
ATTN: MICHELLE SHIH PHONE NO : 886 2 66003631
NO. 8, JIANG YIN ROAD SE DECISION MADE: 10-DEC-08
YI TANG TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
PIZHOU, JIANGSU, CHINA
DEVICE: ELECSYS RUBELLA IGG IMMUNOASSAY
ROCHE DIAGNOSTICS CORP. 510(k) NO: K072617(TRADITIONAL)
ATTN: THERESA A BUSH PHONE NO : 317-521-3723
9115 HAGUE RD. SE DECISION MADE: 05-DEC-08
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MARVEL WHEELCHAIR, MODEL EDCAL01
ROGUE WHEELS INC 510(k) NO: K082970(TRADITIONAL)
ATTN: KATHRYN RONALDS PHONE NO : 905 689 3980
4 INNOVATION DRIVE SE DECISION MADE: 12-DEC-08
DUNDAS, ONTARIO, CANADA L9H 7P3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
RZ MEDIZINTECHNIK GMBH 510(k) NO: K082902(TRADITIONAL)
ATTN: ANGELIKA SCHERP PHONE NO : 312 042 89591
AMSTEL 320-1 SE DECISION MADE: 10-DEC-08
AMSTERDAM, NETHERLANDS 1017AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSTASYL PASTE
SATELEC 510(k) NO: K082116(TRADITIONAL)
ATTN: RICK ROSATI PHONE NO : 800-289-6367
124 GAITHER DRIVE SE DECISION MADE: 17-DEC-08
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
SCIVOLUTIONS, INC. 510(k) NO: K082208(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 01-DEC-08
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZUMA, MODEL 55-XXXX/56-XXXX
SEASPINE, INC. 510(k) NO: K082926(TRADITIONAL)
ATTN: JEFF BRITTAN PHONE NO : 760-727-8399
2302 LA MIRADA DR. SE DECISION MADE: 22-DEC-08
VISTA, CA 92081-7862 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SEDAT FLAMINGO
SEDAT 510(k) NO: K082755(SPECIAL)
ATTN: CHARLES COUSIN PHONE NO : 858-366-5076
8895 TOWNE CENTRE DRIVE SE DECISION MADE: 15-DEC-08
105-416 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92122
DEVICE: HUBANG, MODEL HBL13/HBG12-S
SHANGHAI HUBANG MEDICAL APPLIANCES510(k) NO: K083044(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 422 465396
14F-2, NO.1, LANE 25 SE DECISION MADE: 12-DEC-08
ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, CHINA (TAIWAN) 220
DEVICE: SHARPS COMPLIANCE CONTAINER
SHARPS COMPLIANCE, INC. 510(k) NO: K083129(TRADITIONAL)
ATTN: AL ALADWANI PHONE NO : 713-660-3526
9220 KIRBY DR., SUITE 500 SE DECISION MADE: 15-DEC-08
HOUSTON, TX 77054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K083505(TRADITIONAL)
ATTN: TAN CHAUNBIN PHONE NO : 867 552 6582888
MINDRAY BUILDING, KEJI 12TH RD SE DECISION MADE: 12-DEC-08
SOUTH, HI-TECH INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
NANSHAN,SHENZHEN, P.R. CHINA, CHINTHIRD PARTY REVIEW
DEVICE: DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC
SHIMADZU MEDICAL SYSTEMS 510(k) NO: K082224(TRADITIONAL)
ATTN: DON KARLE PHONE NO : 310-217-8855
20101 SOUTH VERMONT AVE. SE DECISION MADE: 15-DEC-08
TORRANCE, CA 90502-1328 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BEAUTIBOND
SHOFU DENTAL CORP. 510(k) NO: K082744(TRADITIONAL)
ATTN: DAVID P MORAIS PHONE NO : 760-736-3277
1225 STONE DR. SE DECISION MADE: 11-DEC-08
SAN MARCOS, CA 92078 510(k) STATEMENT
DEVICE: DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE,
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K071474(TRADITIONAL)
ATTN: GEORGE M PLUMMER PHONE NO : 302-631-9798
MS 514, PO BOX 6101 SE DECISION MADE: 10-DEC-08
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG
SIEMENS HEALTHCARE DIAGNOSTICS 510(k) NO: K082503(TRADITIONAL)
ATTN: ANNA MARIE KATHLEEN ENNIS PHONE NO : 302-631-9352
500 GBC SE DECISION MADE: 19-DEC-08
PO BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: SIEMENS ACUSON 2000 ULTRASOUND SYSTEM WITH ABVS TRANSDUCER
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K081148(TRADITIONAL)
ATTN: SHEILA PICKERING PHONE NO : 650-943-7187
1230 SHOREBIRD WAY SE DECISION MADE: 22-DEC-08
P O BOX 7393 510(k) SUMMARY AVAILABLE FROM FDA
MOUNTAIN VIEW, CA 94039-7393
DEVICE: PROSIT WOUND TREATMENT DEVICE
SILVERLEAF MEDICAL PRODUCTS, INC. 510(k) NO: K081977(TRADITIONAL)
ATTN: JEFFRY SKIBA PHONE NO : 480-921-4948
1100 E UNIVERSITY DRIVE SE DECISION MADE: 01-DEC-08
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
TEMPE, AZ 85281
DEVICE: HELIODENT PLUS
SIRONA DENTAL SYSTEMS GMBH 510(k) NO: K083344(TRADITIONAL)
ATTN: FRITZ KOLLE PHONE NO :
FABRIKSTRASSE 31 SE DECISION MADE: 23-DEC-08
BENSHEIM, GERMANY D-64625 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT
SMITHS MEDICAL MD, INC. 510(k) NO: K082783(TRADITIONAL)
ATTN: PHIL NEURURER PHONE NO : 651-628-7592
1265 GREY FOX RD. SE DECISION MADE: 17-DEC-08
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
SORIN GROUP DEUTSCHLAND GMBH 510(k) NO: K082344(TRADITIONAL)
ATTN: ROSINA ROBINSON PHONE NO : 508-643-0434
49 PLAIN STREET SE DECISION MADE: 17-DEC-08
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENDOSSEOUS DENTAL IMPLANT SYSTEM
SOUTHERN IMPLANTS, INC. 510(k) NO: K082651(TRADITIONAL)
ATTN: GRETA M HOLS PHONE NO : 866-700-2100
5 HOLLAND BLDG 209 SE DECISION MADE: 22-DEC-08
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRA GUIDEWIRE INTRODUCER NEEDLE
SPECTRA MEDICAL DEVICES, INC. 510(k) NO: K082580(TRADITIONAL)
ATTN: AGUSTIN TURRIZA PHONE NO : 978-657-0889
260-H FORDHAM RD SE DECISION MADE: 08-DEC-08
WILMINGTON, MA 01887 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRANETICS CROSS-PILOT TURBO ELITE SUPPORT CATHETER
SPECTRANETICS CORP. 510(k) NO: K082559(TRADITIONAL)
ATTN: MICHAEL K HANDLEY PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 11-DEC-08
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRANETICS QUICK-CROSS EXTREME SUPPORT CATHETERS
SPECTRANETICS CORP. 510(k) NO: K082561(TRADITIONAL)
ATTN: MICHAEL K HANDLEY PHONE NO : 719-633-8333
96 TALAMINE CT. SE DECISION MADE: 10-DEC-08
COLORADO SPRINGS, CO 80907-5159 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERCURY SPINAL SYSTEM
SPINAL ELEMENTS, INC. 510(k) NO: K083230(SPECIAL)
ATTN: KERRI DIMARTINO PHONE NO : 760-607-1816
2744 LOKER AVE. W. SUITE 100 SE DECISION MADE: 03-DEC-08
CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPSURE(R) PS SYSTEM
SPINE WAVE, INC. 510(k) NO: K083353(SPECIAL)
ATTN: ROAIDA RIZKALLAH PHONE NO : 203-944-9494
TWO ENTERPRISE DR. SE DECISION MADE: 11-DEC-08
SUITE 302 510(k) SUMMARY AVAILABLE FROM FDA
SHELTON, CT 06484
DEVICE: ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
SPINEART 510(k) NO: K081165(TRADITIONAL)
ATTN: FRANCK PENNESI PHONE NO : 41 22 7994025
COINTRIN 20 ROUTE DE PRE-BOIS SE DECISION MADE: 17-DEC-08
CP1813 510(k) SUMMARY AVAILABLE FROM FDA
GENEVA, SWITZERLAND 1215
DEVICE: AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
ST. JUDE MEDICAL 510(k) NO: K081645(SPECIAL)
ATTN: MAC MCKEEN PHONE NO : 952-351-1544
14901 DEVEAU PL. SE DECISION MADE: 09-DEC-08
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPS AIM SL SLITTABLE INNER CATHETER
ST. JUDE MEDICAL 510(k) NO: K082932(SPECIAL)
ATTN: COLLEEN CANAN PHONE NO : 818-493-2960
15900 VALLEY VIEW COURT SE DECISION MADE: 12-DEC-08
SYLMAR,, CA 91342 510(k) STATEMENT
DEVICE: AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323
ST. JUDE MEDICAL 510(k) NO: K083402(SPECIAL)
ATTN: MAC MCKEEN PHONE NO : 952-351-1544
14901 DEVEAU PL. SE DECISION MADE: 15-DEC-08
MINNETONKA, MN 55345-2126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED ENT SHAVERS
STERILMED, INC. 510(k) NO: K081814(TRADITIONAL)
ATTN: JOSHUA CLARIN PHONE NO : 612-644-8402
11400 73RD AVE. N, STE. 100 SE DECISION MADE: 17-DEC-08
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMSCO EVOLUTION MEDIUM STEAM STERILIZER
STERIS CORPORATION 510(k) NO: K082435(ABBREVIATED)
ATTN: ROBERT F SULLIVAN PHONE NO : 440-392-7695
5960 HEISLEY RD. SE DECISION MADE: 30-DEC-08
MENTOR, OH 44060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMAFLO II
STIHLER ELECTRONIC GMBH 510(k) NO: K082758(SPECIAL)
ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059
30 NORTHPORT RD. SE DECISION MADE: 19-DEC-08
SOUND BEACH, NY 11789-1734 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASTOFLO PLUS
STIHLER ELECTRONIC GMBH 510(k) NO: K082765(TRADITIONAL)
ATTN: STEPHEN T MLCOCH PHONE NO : 631-744-0059
30 NORTHPORT RD. SE DECISION MADE: 18-DEC-08
SOUND BEACH, NY 11789-1734 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER LED LIGHT SOURCE (L9000)
STRYKER CORP. 510(k) NO: K082813(TRADITIONAL)
ATTN: DESIREE CRISOLO PHONE NO : 408-754-2784
5900 OPTICAL COURT SE DECISION MADE: 19-DEC-08
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER VIDEOSCOPE
STRYKER ENDOSCOPY 510(k) NO: K082451(TRADITIONAL)
ATTN: DESIREE CRISOLO PHONE NO : 408-754-2784
5900 OPTICAL CT. SE DECISION MADE: 16-DEC-08
SAN JOSE, CA 95138 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER DISPOSABLE CRANIAL PERFORATOR BIT
STRYKER IRELAND LTD., INSTRUMENTS 510(k) NO: K082010(TRADITIONAL)
ATTN: COLETTE O'CONNOR PHONE NO : 353 21 4532978
CARRIGTWOHILL BUSINESS & SE DECISION MADE: 29-DEC-08
TECHNOLOGY PARK 510(k) SUMMARY AVAILABLE FROM FDA
CARRIGTWOHILL, CO.CORK, IRELAND
DEVICE: SUINSA DIAGNOSTIC X-RAY SYSTEM
SUINSA 510(k) NO: K083109(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
P.O. BOX 7007 SE DECISION MADE: 04-DEC-08
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUICKIE RHYTHM
SUNRISE MEDICAL HHG, INC. 510(k) NO: K083249(SPECIAL)
ATTN: JAMES W LEWIS PHONE NO : 303-218-4505
7477 EAST DRY CREEK PKWY. SE DECISION MADE: 23-DEC-08
LONGMONT, CO 80503 510(k) STATEMENT
DEVICE: COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE
SURGICAL DEVICES, A GLOBAL BUSINES510(k) NO: K082535(TRADITIONAL)
ATTN: TIM M LOHNES PHONE NO : 203-492-6060
60 MIDDLETOWN AVE SE DECISION MADE: 01-DEC-08
NORTH HAVEN, CT 06473 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AIRSEAL OPTICAL TROCAR & CANNULA SYSTEM
SURGIQUEST, INC. 510(k) NO: K083211(TRADITIONAL)
ATTN: KOUROSH AZARBARZIN PHONE NO : 203-799-2400
12 CASCADE BLVD. SE DECISION MADE: 15-DEC-08
SUITE 2B 510(k) SUMMARY AVAILABLE FROM FDA
ORANGE, CT 06477
DEVICE: HERCULITE ULTRA
SYBRON DENTAL SPECIALTIES 510(k) NO: K082671(TRADITIONAL)
ATTN: WENDY GARMAN PHONE NO : 714-516-7602
1717 WEST COLLINS AVENUE SE DECISION MADE: 11-DEC-08
ORANGE, CA 92867 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
SYNTHES (USA) 510(k) NO: K082625(TRADITIONAL)
ATTN: KARL J NITTINGER PHONE NO : 610-719-6941
1301 GOSHEN PKWY. SE DECISION MADE: 17-DEC-08
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
SYNTHES (USA) 510(k) NO: K083213(TRADITIONAL)
ATTN: SHERI L MUSGNUNG PHONE NO : 610-719-6940
1301 GOSHEN PKWY. SE DECISION MADE: 30-DEC-08
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAMPFIX
SYNTHES SPINE 510(k) NO: K082914(TRADITIONAL)
ATTN: JASON LIPMAN PHONE NO : 610-719-5629
1302 WRIGHTS LANE EAST SE DECISION MADE: 11-DEC-08
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K081715(SPECIAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 17-DEC-08
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 248
DEVICE: PRO GLUCOSE TEST STRIP
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K082169(TRADITIONAL)
ATTN: YUHUA CHEN PHONE NO : 886 266 258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 04-DEC-08
WUGU TOWNSHIP 510(k) SUMMARY AVAILABLE FROM FDA
TAIPEI COUNTY, CHINA (TAIWAN) 241
DEVICE: TAIDOC TD-11 SERIES AND CLEVER TD-1112 EAR/SKIN/ SURFACE IR THER
TAIDOC TECHNOLOGY CORPORATION 510(k) NO: K083299(SPECIAL)
ATTN: JEFF WANG PHONE NO : 886 2 66258188
6F, NO. 127, WUGONG 2ND RD SE DECISION MADE: 10-DEC-08
WUGU TOWNSHIP 510(k) STATEMENT
TAIPEI COUNTY, CHINA (TAIWAN) 248
DEVICE: PRIMATRIX DERMAL REPAIR SCAFFOLD
TEI BIOSCIENCES INC. 510(k) NO: K083440(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 12-DEC-08
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: X-COATED TERUMO AND SARNS DUAL STAGE VENOUS RETURN CATHETERS, SA
TERUMO CARDIOVASCULAR SYSTEMS CORP510(k) NO: K083301(SPECIAL)
ATTN: JUNKO KUROSAWA PHONE NO : 734-663-4145
6200 JACKSON RD. SE DECISION MADE: 18-DEC-08
ANN ARBOR, MI 48103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRANIAL PERFORATOR
THE ANSPACH EFFORT, INC. 510(k) NO: K082637(TRADITIONAL)
ATTN: JIM BANIC PHONE NO : 561-627-1080
4500 RIVERSIDE DR. SE DECISION MADE: 22-DEC-08
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KEY RING ALCOHOL BREATHALYZER
THE ASHLEY COLLECTION, INC. 510(k) NO: K082086(TRADITIONAL)
ATTN: ROBERT GOLDY PHONE NO : 212-247-7294
600 WEST 57TH ST. SE DECISION MADE: 19-DEC-08
NEW YORK, NY 10019 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
THE BINDING SITE, LTD. 510(k) NO: K081827(TRADITIONAL)
ATTN: JAY H GELLER PHONE NO : 310-449-1399
WEST TOWER, SUITE 4000 SE DECISION MADE: 19-DEC-08
2425 WEST OLYMPIC BOULEVARD 510(k) STATEMENT
SANTA MONICA, CA 90404
DEVICE: MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
THE MAGSTIM COMPANY LTD. 510(k) NO: K080499(TRADITIONAL)
ATTN: ANWEN EVANS PHONE NO : 441 994 240798
SPRING GARDENS, WHITLAND SE DECISION MADE: 08-DEC-08
DYFED, WALES, UNITED KINGDOM SA34 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RSVP HALF SPHERE PHANTOM, MODEL DDP010
THE PHANTOM LABORATORY, INC. 510(k) NO: K082909(TRADITIONAL)
ATTN: JOSHUA R LEVY PHONE NO : 518-692-1190
P.O. BOX 511 SE DECISION MADE: 23-DEC-08
SALEM, NY 12865-0511 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACI
THERMO FISHER SCIENTIFIC 510(k) NO: K081083(TRADITIONAL)
ATTN: JACK ROGERS PHONE NO : 317-610-3823
46360 FREMONT BLVD. SE DECISION MADE: 19-DEC-08
FREMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TIVAMED COOLED RF SYSTEM, MODEL 78001
TIVAMED, INC. 510(k) NO: K082962(TRADITIONAL)
ATTN: SHELLEY TRIMM PHONE NO : 707-508-5527
4410 EL CAMINO REAL, SUITE 204 SE DECISION MADE: 04-DEC-08
LOS ALTOS, CA 94022 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
TOBY ORTHOPAEDICS, LLC 510(k) NO: K081608(TRADITIONAL)
ATTN: AL WEISENBORN PHONE NO : 305-829-3437
3773 MATHESON AVENUE SE DECISION MADE: 19-DEC-08
MIAMI, FL 33133 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMAGE-ARENA APPLICATIONS
TOMTEC IMAGING SYSTEMS, GMBH 510(k) NO: K083348(TRADITIONAL)
ATTN: INGE SCHEIDT PHONE NO : 49 89 32175830
EDISONSTRASSE 6 SE DECISION MADE: 23-DEC-08
UNTERSCHLEISSHEIM, GERMANY D-85716510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODEL RSX-301B AQUILION CT SYSTEM
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K083282(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 12-DEC-08
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: KODAK 9500
TROPHY 510(k) NO: K082972(TRADITIONAL)
ATTN: MARIE-PIERRE LABAT-CAMY PHONE NO : 331 648 08500
4 RUE F. PELLOUTIER CROISSY SE DECISION MADE: 05-DEC-08
BEAUBOURG 510(k) STATEMENT
MARNE LA VALLEE CEDEX 2, FRANCE 77437
DEVICE: TRULY AUTOMATIC BLOOD PRESSURE MONITOR, MODEL DB11
TRULY INSTRUMENT LIMITED 510(k) NO: K081852(TRADITIONAL)
ATTN: YANG JIANHAO PHONE NO : 86 660 3380070
TRULY INDUSTRIAL AREA SE DECISION MADE: 12-DEC-08
SHANWEI CITY, GUANGDONG, CHINA 516510(k) STATEMENT
DEVICE: TT1 GENERAL PURPOSE COIL
TURSIOP TECHNOLOGIES LLC 510(k) NO: K083434(TRADITIONAL)
ATTN: PHONE NO :
11000 CEDAR AVE., SUITE 280 SE DECISION MADE: 23-DEC-08
CLEVELAND, OH 44106 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NUOVOCATH
U.S. SAFETY SYRINGES CO., INC. 510(k) NO: K083454(TRADITIONAL)
ATTN: CHRISTINE SMITH PHONE NO : 888-729-9674
1676 VILLAGE GREEN SE DECISION MADE: 04-DEC-08
CROFTON, MD 21114 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FING
UNIMED MEDICAL SUPPLIES INC. 510(k) NO: K082546(TRADITIONAL)
ATTN: DON MELNIKOFF PHONE NO : 262-565-6797
W322S8863 MCCARTHY DR. SE DECISION MADE: 02-DEC-08
MUKWONAGO, WI 53149 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: "UNITED" U2 TOTAL KNEE SYSTEM
UNITED ORTHOPEDIC CORP. 510(k) NO: K082424(TRADITIONAL)
ATTN: RUDY CHEN PHONE NO : 886 3 5773351
57 PARK AVE. 2, SCIENCE PARK SE DECISION MADE: 16-DEC-08
HSINCHU, CHINA (TAIWAN) 300 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEARTRAK SMART ECAT
UNIVERSAL MEDICAL, INC. 510(k) NO: K083535(TRADITIONAL)
ATTN: JOYCE W DEAN PHONE NO : 800-606-5511
275 PHILLIPS BLVD. SE DECISION MADE: 15-DEC-08
EWING, NJ 08618 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: URONIRS, MODEL 2000
URODYNAMIX TECHNOLOGIES LTD 510(k) NO: K082701(TRADITIONAL)
ATTN: ANDRE KINDSVATER PHONE NO : 604 638 0244
1485-555 BURRARD STREET SE DECISION MADE: 18-DEC-08
BOX 213 510(k) SUMMARY AVAILABLE FROM FDA
VANCOUVER BC, CANADA V7X 1M9
DEVICE: PHANTOM PLUS CAGE SYSTEM
US SPINE 510(k) NO: K082801(TRADITIONAL)
ATTN: PETER HARRIS PHONE NO : 561-367-7463
3600 FAU BLVD. SE DECISION MADE: 22-DEC-08
SUITE 101 510(k) SUMMARY AVAILABLE FROM FDA
BOCA RATON, FL 33431
DEVICE: GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
VASCULAR SOLUTIONS, INC. 510(k) NO: K080022(TRADITIONAL)
ATTN: DEBORAH NEYMARK PHONE NO : 763-656-4300
6464 SYCAMORE COURT SE DECISION MADE: 09-DEC-08
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FLOWPICC CATHETER
VASONOVA INC. 510(k) NO: K082481(TRADITIONAL)
ATTN: TINA CHENG PHONE NO : 510-589-6084
1368 BORDEAUX DR., SUITE 100 SE DECISION MADE: 17-DEC-08
SUNNYVALE, CA 94089 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600
VERATHON INCORPORATED 510(k) NO: K082456(ABBREVIATED)
ATTN: RICHARD A ZEINE PHONE NO : 425-867-1348
20001 NORTH CREEK PKWY SE DECISION MADE: 01-DEC-08
BOTHEL, WA 98011 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VIATRONIX V3D-CARDIAC, REVISION 1.0
VIATRONIX, INC. 510(k) NO: K083293(TRADITIONAL)
ATTN: DONGQING CHEN PHONE NO : 631-444-9634
25 HEALTH SCIENCES DR. SE DECISION MADE: 05-DEC-08
SUITE 203/204 510(k) SUMMARY AVAILABLE FROM FDA
STONY BROOK, NY 11790 THIRD PARTY REVIEW
DEVICE: VICOR PD2I ANALYZER, VERSION 2.1
VICOR TECHNOLOGIES, INC. 510(k) NO: K082709(TRADITIONAL)
ATTN: JULES MITCHEL PHONE NO : 212-681-2100
261 MADISON AVE. 24TH FLOOR SE DECISION MADE: 29-DEC-08
NEW YORK, NY 10016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISAGE PACS, VERSION 6.0/CS 3.1
VISAGE IMAGING, INC. 510(k) NO: K082269(TRADITIONAL)
ATTN: STEFAN STROWICH PHONE NO : 49 30 70096841
LEPSIUSSTRASSE 70 SE DECISION MADE: 12-DEC-08
BERLIN, GERMANY 12163 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VISIONSENSE STEREOSCOPIC VISION SYSTEM
VISIONSENSE, LTD. 510(k) NO: K082355(TRADITIONAL)
ATTN: GERARD J PRUD'HOMME PHONE NO : 202-637-5735
555 13TH STREET, NW SE DECISION MADE: 15-DEC-08
WASHINGTON, DC 20004 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MRI-PLAQUE VIEW, VERSION 1.1.2003
VPDIAGNOSTICS, INC 510(k) NO: K082607(TRADITIONAL)
ATTN: MICHAEL HARTMANN PHONE NO : 206-428-6160
819 VIRGINIA ST SE DECISION MADE: 05-DEC-08
SUITE 2209 510(k) SUMMARY AVAILABLE FROM FDA
SEATTLE, WA 98101
DEVICE: CONSERVE PRESSFIT FEMORAL COMPONENT
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K082673(TRADITIONAL)
ATTN: THERESA LEISTER PHONE NO : 901-867-4143
5677 AIRLINE RD. SE DECISION MADE: 12-DEC-08
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COMBOCARE 2000
XANACARE TECHNOLOGIES, LLC 510(k) NO: K083202(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-463-0900
13605 W. 7TH AVE. SE DECISION MADE: 15-DEC-08
GOLDEN, CO 80401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
ZEFON INTL. 510(k) NO: K082630(ABBREVIATED)
ATTN: SCOTT RYAN PHONE NO : 352-854-8080
5350 S.W. FIRST LN. SE DECISION MADE: 19-DEC-08
OCALA, FL 34474 510(k) STATEMENT
DEVICE: ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
ZIMMER DENTAL INC. 510(k) NO: K082639(TRADITIONAL)
ATTN: WILLIAM FISHER PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 19-DEC-08
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER ANGLED CONTOUR ZIRCONIA ABUTMENT
ZIMMER DENTAL INC. 510(k) NO: K083474(SPECIAL)
ATTN: WILLIAM FISHER PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 23-DEC-08
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREW
ZIMMER, INC. 510(k) NO: K082527(TRADITIONAL)
ATTN: ANTHONY FRANCALANCIA PHONE NO : 574-372-4570
P.O. BOX 708 SE DECISION MADE: 18-DEC-08
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL
ZIMMER, INC. 510(k) NO: K082770(TRADITIONAL)
ATTN: DANIEL J WILLIMAN PHONE NO : 574-371-8065
P.O. BOX 708 SE DECISION MADE: 11-DEC-08
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CT BRAIN PERFUSION FOR ZIOSTATION
ZIOSOFT, INC. 510(k) NO: K083084(TRADITIONAL)
ATTN: RICHARD BALL PHONE NO : 650-413-1364
2200 BRIDGE PARKWAY, SUITE 103 SE DECISION MADE: 19-DEC-08
REDWOOD CITY, CA 94065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL E SERIES WITH INTIBATION ASSIST OPTION
ZOLL MEDICAL CORPORATION 510(k) NO: K080903(SPECIAL)
ATTN: EILEEN M BOYLE PHONE NO : 978-421-9171
269 MILL ROAD SE DECISION MADE: 04-DEC-08
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL R SERIES BLS DEFIBRILLATOR
ZOLL MEDICAL CORPORATION 510(k) NO: K081828(TRADITIONAL)
ATTN: EILEEN M BOYLE PHONE NO : 978-421-9171
269 MILL ROAD SE DECISION MADE: 09-DEC-08
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 277
TOTAL WITH SUMMARIES 250
TOTAL WITH STATEMENTS 27
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