510(k)s Final Decisions Rendered for May 2006
SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-MAY-2006 THROUGH 31-MAY-2006
DEVICE: MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN
<GENX> INTL., INC. 510(k) NO: K053551(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW RD. SE DECISION MADE: 09-MAY-06
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA
<GENX> INTL., INC. 510(k) NO: K053552(TRADITIONAL)
ATTN: MICHAEL D CECCHI PHONE NO : 203-453-1700
393 SOUNDVIEW RD. SE DECISION MADE: 19-MAY-06
GUILFORD, CT 06437 510(k) STATEMENT
DEVICE: TOTAL BILIRUBIN
ABBOT LABORATORIES 510(k) NO: K060574(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1921 HURD DRIVE SE DECISION MADE: 03-MAY-06
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARBON DIOXIDE
ABBOTT LABORATORIES 510(k) NO: K060295(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1921 HURD DR. SE DECISION MADE: 04-MAY-06
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCOSE
ABBOTT LABORATORIES 510(k) NO: K060383(TRADITIONAL)
ATTN: LINDA MORRIS PHONE NO : 972-518-6711
1921 HURD DR. SE DECISION MADE: 05-MAY-06
IRVING, TX 75038 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RELIENT NAVIGATION DEVICE
ACCLARENT, INC. 510(k) NO: K060974(SPECIAL)
ATTN: SU-MIEN CHONG PHONE NO : 650-687-5888
1525-B O'BRIEN DR. SE DECISION MADE: 05-MAY-06
MENLO PARK, CA 94025 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACCUTECH ENDOLITE PROBE
ACCUTECH MEDICAL TECHNOLOGIES, INC510(k) NO: K061025(TRADITIONAL)
ATTN: ANNE WORDEN PHONE NO : 925-895-1200
3637 BERNAL AVE SE DECISION MADE: 31-MAY-06
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOFUSER
ACE MEDICAL US, LLC 510(k) NO: K060258(TRADITIONAL)
ATTN: ANDY LAMBORNE PHONE NO : 303-443-7500
9102 TURFWAY BEND DR. SE DECISION MADE: 30-MAY-06
POWELL, OH 43065-8497 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACMI DUR-HL LASER SYSTEMS
ACMI CORPORATION 510(k) NO: K060752(TRADITIONAL)
ATTN: LORRAINE CALZETTA PHONE NO : 508-804-2752
136 TURNPIKE RD. SE DECISION MADE: 25-MAY-06
SOUTHBOROUGH, MA 01772 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC
ACON LABORATORIES, INC. 510(k) NO: K060925(TRADITIONAL)
ATTN: EDWARD TUNG PHONE NO : 858-535-2030
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 09-MAY-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET0
ACRO BIOTECH LLC. 510(k) NO: K053035(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-893-7749
9500 7TH STREET UNIT M SE DECISION MADE: 05-MAY-06
RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT
DEVICE: ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000
ACRO BIOTECH LLC. 510(k) NO: K060353(TRADITIONAL)
ATTN: GREGORY LEE PHONE NO : 778-322-4651
9500 7TH STREET UNIT M SE DECISION MADE: 03-MAY-06
RANCHO CUCAMONGA, CA 91730-9094 510(k) STATEMENT
DEVICE: DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDA
AD-TECH MEDICAL INSTRUMENT CORP. 510(k) NO: K053358(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 25-MAY-06
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL E
AD-TECH MEDICAL INSTRUMENT CORP. 510(k) NO: K053363(ABBREVIATED)
ATTN: GARY SYRING PHONE NO : 608-877-2635
800 LEVANGER LANE SE DECISION MADE: 30-MAY-06
STOUGHTON, WI 53589 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JETSTREAM WORKSPACE
ADAC LABORATORIES 510(k) NO: K061029(TRADITIONAL)
ATTN: LORI R PETERSON PHONE NO : 408-468-3042
540 ALDER DR. SE DECISION MADE: 01-MAY-06
MILPITAS, CA 95035 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: S. AUREUS PNA FISH
ADVANDX, INC. 510(k) NO: K060099(TRADITIONAL)
ATTN: AMY AUWLES PHONE NO : 781-329-2993
690 CANTON STREET, SUITE 302 SE DECISION MADE: 08-MAY-06
WESTWOOD, MA 02090 510(k) STATEMENT
DEVICE: FLIGHT
AERO INNOVATIVE RESEARCH, INC. 510(k) NO: K061186(TRADITIONAL)
ATTN: MATT COCHRAN PHONE NO : 316-755-3477
500 W. CLAY ST SE DECISION MADE: 12-MAY-06
VALLEY CENTER, KS 67147 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE
AESCULAP, INC. 510(k) NO: K053579(SPECIAL)
ATTN: MATTHEW M HULL PHONE NO : 610-984-9072
3773 CORPORATE PKWY. SE DECISION MADE: 17-MAY-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AESCULAP BIPOLAR ACETABULAR CUP
AESCULAP, INC. 510(k) NO: K060707(TRADITIONAL)
ATTN: MATTHEW M HULL PHONE NO : 800-258-1946
3773 CORPORATE PKWY. SE DECISION MADE: 31-MAY-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD
AESCULAP, INC. 510(k) NO: K060918(SPECIAL)
ATTN: KATHY A RACOSKY PHONE NO : 610-984-9291
3773 CORPORATE PARKWAY SE DECISION MADE: 26-MAY-06
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RINSENDO
AIR TECHNIQUES, INC. 510(k) NO: K052271(TRADITIONAL)
ATTN: JOSEPH CAREY PHONE NO : 516-214-5541
70 CANTIAGUE ROCK RD. SE DECISION MADE: 26-MAY-06
HICKSVILLE, NY 11801 510(k) STATEMENT
DEVICE: TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE W
AIRWAY MANAGEMENT INC. 510(k) NO: K060388(TRADITIONAL)
ATTN: DARREN HENDERSON PHONE NO : 214-369-0978
6116 NORTH CENTRAL EXPRESSWAY SE DECISION MADE: 17-MAY-06
SUITE 605 510(k) SUMMARY AVAILABLE FROM FDA
DALLAS, TX 75206
DEVICE: PARA-PRO FC50
ALPHA-TEC SYSTEMS, INC. 510(k) NO: K053257(TRADITIONAL)
ATTN: RICHARD WILLIAMS PHONE NO : 360-260-2779
12019 N.E. 99TH ST., #1780 SE DECISION MADE: 12-MAY-06
VANCOUVER, WA 98682 510(k) STATEMENT
DEVICE: RAPIDTOX
AMERICAN BIO MEDICA CORP. 510(k) NO: K053359(SPECIAL)
ATTN: FRAN WHITE PHONE NO : 978-927-3808
163 CABOT ST. SE DECISION MADE: 25-MAY-06
BEVERLY, MA 01915 510(k) STATEMENT
DEVICE: ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK
AMERICAN DIAGNOSTIC CORP. 510(k) NO: K060321(TRADITIONAL)
ATTN: MICHAEL FALCO PHONE NO : 631-273-9600
55 COMMERCE DR. SE DECISION MADE: 15-MAY-06
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM
APEX MEDICAL TECHNOLOGIES, INC. 510(k) NO: K060933(TRADITIONAL)
ATTN: WHITNEY WILLIAMS PHONE NO : 858-535-0012
10064 MESA RIDGE CT., #202 SE DECISION MADE: 09-MAY-06
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ARCADIA MEDICAL SILICONE WIRE REINFORCED ENDOTRACHEAL TUBES
ARCADIA MEDICAL CORPORATION 510(k) NO: K060094(TRADITIONAL)
ATTN: MARK FOOTE PHONE NO : 847-330-4447
1450 EAST AMERICAN LANE SE DECISION MADE: 08-MAY-06
SUITE 1400 510(k) SUMMARY AVAILABLE FROM FDA
SCHAUMBURG, IL 60173
DEVICE: PYLO-PLUS
ARJ MEDICAL, INC. 510(k) NO: K052708(TRADITIONAL)
ATTN: PHILIP ROSS PHONE NO : 813-855-1557
209 STATE STREET SE DECISION MADE: 01-MAY-06
OLDSMAR, FL 34677 510(k) STATEMENT
DEVICE: ARTHREX BIO-COMPRESSION SCREW
ARTHREX, INC. 510(k) NO: K060478(TRADITIONAL)
ATTN: ANN WATERHOUSE PHONE NO : 239-643-5553
1370 CREEKSIDE BLVD. SE DECISION MADE: 19-MAY-06
NAPLES, FL 34108-1945 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO ARTHROCARE PERC-D SPINEWAND
ARTHROCARE CORP. 510(k) NO: K061259(SPECIAL)
ATTN: VALERIE DEFIESTA-NG PHONE NO : 408-736-0224
680 VAQUEROS AVE. SE DECISION MADE: 18-MAY-06
SUNNYVALE, CA 94085-3523 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASCENSION PYROSPHERE CMC/TMT
ASCENSION ORTHOPEDICS, INC. 510(k) NO: K060560(TRADITIONAL)
ATTN: GLEN NEALLY PHONE NO : 512-836-5001
8700 CAMERON RD., STE. 100 SE DECISION MADE: 05-MAY-06
AUSTIN, TX 78754-3832 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BC100 BODY COMPOSITION ANALYSIS SYSTEM
ATHLETIC IQ, INC. 510(k) NO: K060552(TRADITIONAL)
ATTN: PAMELA PAPINEAU PHONE NO : 978-772-3552
5 WHITCOMB AVENUE SE DECISION MADE: 24-MAY-06
AYER, MA 01432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IVENA VASCULAR PATCH
ATRIUM MEDICAL CORP. 510(k) NO: K060396(TRADITIONAL)
ATTN: JOSEPH P DE PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DR. SE DECISION MADE: 12-MAY-06
HUDSON, NH 03051 510(k) STATEMENT
DEVICE: HOT DOG PATIENT WARMING SYSTEM
AUGUSTINE BIOMEDICAL & DESIGN, LLC510(k) NO: K052392(TRADITIONAL)
ATTN: JAMES D ECKLEIN PHONE NO : 952-465-3500
6581 CITY WEST PARKWAY SE DECISION MADE: 04-MAY-06
EDEN PRAIRIE, MN 55344 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
AUSTRALIAN SURGICAL DESIGN & MANUF510(k) NO: K060412(TRADITIONAL)
ATTN: JAMES F LOGAN PHONE NO : 410-793-0484
2530 RIVA ROAD, SUITE 308 SE DECISION MADE: 17-MAY-06
ANNAPOLIS, MD 21401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DRX9000 TRUE SPINAL DECOMPRESSION SYSTEM
AXIOM WORLDWIDE, INC. 510(k) NO: K060735(TRADITIONAL)
ATTN: JIM GIBSON PHONE NO : 813-249-6444
9423 CORPORATE LAKE DRIVE SE DECISION MADE: 26-MAY-06
TAMPA, FL 33634 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ORTHOMON
AXON SYSTEMS, INC. 510(k) NO: K061113(TRADITIONAL)
ATTN: HOWARD BAILIN PHONE NO : 631-436-5112
400-2200 OSER AVE. SE DECISION MADE: 23-MAY-06
HAUPPAUGE, NY 11788 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VOXAR 3D ENTERPRISE WITH CARDIAMETRIX
BARCOVIEW MIS EDINBURGH 510(k) NO: K061326(TRADITIONAL)
ATTN: NEIL PHILLIPS PHONE NO : 013 147 24792
BONNINGTON BOND, 2 ANDERSON PL SE DECISION MADE: 25-MAY-06
EDINBURGH, LOTHIAN, UNITED KINGDOM510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
BAXTER HEALTHCARE CORPORATION 510(k) NO: K053539(TRADITIONAL)
ATTN: DAVID E CURTIN PHONE NO : 847-473-6079
1620 WAUKEGAN ROAD SE DECISION MADE: 24-MAY-06
MCGAW PARK, IL 60085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
BECKMAN COULTER, INC. 510(k) NO: K061064(TRADITIONAL)
ATTN: NANCY NADLER PHONE NO : 305-380-4191
11800 SW 147TH AVE. SE DECISION MADE: 17-MAY-06
MIAMI, FL 33196-2500 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMI
BECTON DICKINSON & CO. 510(k) NO: K060324(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 25-MAY-06
SPARKS, MD 21152 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64
BECTON, DICKINSON & CO. 510(k) NO: K060558(TRADITIONAL)
ATTN: MONICA E GIGUERE PHONE NO : 410-316-4287
7 LOVETON CIR. SE DECISION MADE: 11-MAY-06
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PURE-AID PREGNANCY TEST
BIO FOCUS CO., LT. 510(k) NO: K053452(TRADITIONAL)
ATTN: LAUREN HONG PHONE NO : 310-532-0009
251E. REDONDO BEACH BLVD. SE DECISION MADE: 25-MAY-06
GARDENA, CA 90248 510(k) STATEMENT
DEVICE: FIDIS DSDNA
BIOMEDICAL DIAGNOSTICS (BMD) SA 510(k) NO: K060380(TRADITIONAL)
ATTN: CHRISTELLE COURIVAUD PHONE NO : 330 164 621012
ACTIPOLE 25 SE DECISION MADE: 02-MAY-06
4-6 BLD DE BEAUBOURG 510(k) SUMMARY AVAILABLE FROM FDA
MARNE LA VALLEE CEDEX 2, FRANCE 77435
DEVICE: VANGUARD REMOVABLE MOLDED POLY TIBIA
BIOMET MANUFACTURING CORP. 510(k) NO: K060525(TRADITIONAL)
ATTN: TRACY BICKEL JOHNSON PHONE NO : 574-367-6639
56 EAST BELL DRIVE SE DECISION MADE: 25-MAY-06
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: COMPREHENSIVE PRIMARY SHOULDER STEMS
BIOMET MANUFACTURING CORP. 510(k) NO: K060692(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 30-MAY-06
56. E. BELL DRIVE 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMEN
BIOMET MANUFACTURING, INC. 510(k) NO: K052639(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 03-MAY-06
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOD CHEMISTRY CONTROL
BIORESOURCE TECHNOLOGY, INC. 510(k) NO: K060850(TRADITIONAL)
ATTN: ERIKA B AMMIRATI PHONE NO : 650-949-2768
575 SHIRLYNN COURT SE DECISION MADE: 30-MAY-06
LOS ALTOS, CA 94022 510(k) STATEMENT
DEVICE: BISCEM TRANSLUCENT, BISCEM OPAQUE
BISCO, INC. 510(k) NO: K060701(TRADITIONAL)
ATTN: BENJAMIN LICHTENWALNER PHONE NO : 847-534-6146
1100 WEST IRVING PARK RD. SE DECISION MADE: 15-MAY-06
SCHAUMBURG, IL 60193 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM
BLUE SKY BIO, LLC 510(k) NO: K060957(SPECIAL)
ATTN: MICHELLE VOVOLKA PHONE NO : 847-548-8499
888 E BELVIDERE RD. SE DECISION MADE: 05-MAY-06
SUITE 212 510(k) SUMMARY AVAILABLE FROM FDA
GRAYSLAKE, IL 60030
DEVICE: ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360,
BOSTON SCIENTIFIC CORPORATION 510(k) NO: K060323(TRADITIONAL)
ATTN: JENNIFER KIMBALL PHONE NO : 508-683-4178
100 BOSTON SCIENTIFIC WAY SE DECISION MADE: 12-MAY-06
MARLBOROUGH, MA 01752 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIES
BRAUN GMBH 510(k) NO: K061199(TRADITIONAL)
ATTN: AMANDA HEFFERNAN PHONE NO : 617-463-9532
800 BOYLSTON ST SE DECISION MADE: 31-MAY-06
PRUDENTIAL TOWER BLDG FL 46 510(k) SUMMARY AVAILABLE FROM FDA
BOSTON, MA 02199-8004
DEVICE: BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
BREAS MEDICAL AB 510(k) NO: K060546(TRADITIONAL)
ATTN: KARL-JOHAN HOLM PHONE NO : 011 463 1868800
FORETAGSVAGEN 1 SE DECISION MADE: 26-MAY-06
MOLNLYCKE, VASTRA GOTALAND, SWEDEN510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREAS, MODEL HA01
BREAS MEDICAL AB 510(k) NO: K060790(SPECIAL)
ATTN: KARL-JOHAN HOLM PHONE NO : 463 186 8800
FORETAGSVAGEN 1 SE DECISION MADE: 25-MAY-06
MOLNLYCKE, SWEDEN SE 435 33 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABLE GLOVE, NITRILE BLUE POWDERED EXAMINATION GLOVES
BRIGHT ELEMENT SDN BHD 510(k) NO: K061074(TRADITIONAL)
ATTN: SEOW L AUDIE PHONE NO : 033 392 8588
OFF JALAN MERU SE DECISION MADE: 24-MAY-06
KLANG SELANGOR DARUL EHSAN, MALAYS510(k) STATEMENT
DEVICE: BRIGHT ELEMENT SND BHD LATEX POWDER FREE EXAMINATION GLOVES
BRIGHT ELEMENT SDN BHD 510(k) NO: K061078(TRADITIONAL)
ATTN: SEOW L AUDIE PHONE NO : 033 392 8588
OFF JALAN MERU SE DECISION MADE: 19-MAY-06
KLANG SELANGOR DARUL EHSAN, MALAYS510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
BRYAN KEROPIAN DDS 510(k) NO: K061228(TRADITIONAL)
ATTN: BRYAN KEROPIAN, DDS PHONE NO : 818-881-7233
18607 VENTURA BLVD., SUITE 206 SE DECISION MADE: 26-MAY-06
TARZANA, CA 91356 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO BODYGUARD INFUSION PUMP SYSTEM
CAESAREA MEDICAL ELECTRONICS LTD. 510(k) NO: K060479(TRADITIONAL)
ATTN: GALI TZURY PHONE NO : 972 4 6271737
16 SHACHAM STREET SE DECISION MADE: 12-MAY-06
P.O.B. 4294 510(k) SUMMARY AVAILABLE FROM FDA
CAESAREA, ISRAEL 38900
DEVICE: CLEARADEX GEL
CAMBRIDGEMED 510(k) NO: K060561(TRADITIONAL)
ATTN: PAUL STRATI PHONE NO : 781-376-4114
800 WEST CUMMINGS PARK SE DECISION MADE: 30-MAY-06
SUITE 2900 510(k) STATEMENT
WOBURN, MA 01801
DEVICE: MODIFICATION TO POWERHEART ECD
CARDIAC SCIENCE CORPORATION 510(k) NO: K060934(SPECIAL)
ATTN: CHERYL SHEA PHONE NO : 425-402-2255
3303 MONTE VILLA PKWY. SE DECISION MADE: 15-MAY-06
BOTHELL, WA 98021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: CARDIMA ABLATION SYSTEM
CARDIMA, INC. 510(k) NO: K060715(SPECIAL)
ATTN: ERIC CHAN PHONE NO : 510-354-0176
47266 BENICIA ST. SE DECISION MADE: 15-MAY-06
FREMONT, CA 94538-1372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR
CHILIN TECHNOLOGY CO. LTD 510(k) NO: K061303(TRADITIONAL)
ATTN: PHIL CHEN PHONE NO : 886 6 2794114
NO. 71, TE LUN ROAD SE DECISION MADE: 25-MAY-06
JEN TE HSIAN, TAINAN COUNTY, CHINA510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: 1.3MP MEDICAL COLOR REFERENCE DISPLAY, MODELS MDC 1900-1LG AND M
CHILIN TECHNOLOGY CO. LTD 510(k) NO: K061305(TRADITIONAL)
ATTN: PHIL CHEN PHONE NO : 886 6 2794114
NO. 71, TE LUN ROAD SE DECISION MADE: 25-MAY-06
JEN TE HSIAN, TAINAN COUNTY, CHINA510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT
CLEARLAB PTE LTD. 510(k) NO: K052290(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
2214 SANFORD DRIVE, B7 SE DECISION MADE: 15-MAY-06
GRAND JUNCTION, CO 81505 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLINIQA LIQUID QC LIPID CONTROL LEVELS 1 & 2;LINICAL LIPID CALIB
CLINIQA CORPORATION 510(k) NO: K061182(TRADITIONAL)
ATTN: CAROL RUGGIERO PHONE NO : 760-744-1900
1432 SOUTH MISSION RD. SE DECISION MADE: 25-MAY-06
FALLBROOK, CA 92028 510(k) STATEMENT
DEVICE: CMA CEREBRAL TISSUE MONITORING SYSTEM
CMA MICRODIALYSIS AB 510(k) NO: K060554(SPECIAL)
ATTN: NANCY BLANCO PHONE NO : 978-251-1940
73 PRINCETON STREET SE DECISION MADE: 02-MAY-06
NORTH CHELMSFORD, MA 01863 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFIED MERCI RETRIEVER, MODEL 90092
CONCENTRIC MEDICAL, INC. 510(k) NO: K061059(SPECIAL)
ATTN: KIRSTEN VALLEY PHONE NO : 650-938-2100
1380 SHOREBIRD WAY SE DECISION MADE: 25-MAY-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
CONMED CORPORATION 510(k) NO: K061112(SPECIAL)
ATTN: IRA DUESLER PHONE NO : 315-624-3072
525 FRENCH ROAD SE DECISION MADE: 22-MAY-06
UTICA, NY 13502 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EV
COOK VASCULAR, INC. 510(k) NO: K061000(SPECIAL)
ATTN: JIM FERGUSON, JR PHONE NO : 724-845-8621
1186 MONTGOMERY LANE SE DECISION MADE: 10-MAY-06
VANDERGRIFT, PA 15690 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
COSMAN MEDICAL, INC. 510(k) NO: K060799(TRADITIONAL)
ATTN: MICHAEL ARNOLD PHONE NO : 781-272-6561
76 CAMBRIDGE ST. SE DECISION MADE: 02-MAY-06
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPORARY CROWN & BRIDGE RESIN
COSMEDENT, INC. 510(k) NO: K060881(TRADITIONAL)
ATTN: JAMES L SANDRIK PHONE NO : 312-644-9395
401 NORTH MICHIGAN AVE. SE DECISION MADE: 16-MAY-06
SUITE 2500 510(k) SUMMARY AVAILABLE FROM FDA
CHICAGO, IL 60611
DEVICE: ACCUREX
CYBERMED, INC. 510(k) NO: K061126(TRADITIONAL)
ATTN: SONG NAK CHOI PHONE NO : 82 2 33973970
#504 SJ TECHNOVILLE, SE DECISION MADE: 09-MAY-06
GASAN-DONG 60-19, GEUMCHEON-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 153-710 THIRD PARTY REVIEW
DEVICE: PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT
CYNOSURE, INC. 510(k) NO: K051442(TRADITIONAL)
ATTN: GEORGE CHO PHONE NO : 978-256-4200
10 ELIZABETH DR. SE DECISION MADE: 24-MAY-06
CHELMSFORD, MA 01824 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF
DADE BEHRING, INC. 510(k) NO: K053337(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
GLASGOW BUSINESS COMMUNITY SE DECISION MADE: 19-MAY-06
BLDG. 500 M.S. 514; POX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
DADE BEHRING, INC. 510(k) NO: K060369(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYON PHONE NO : 781-826-4551
PO BOX 6101 SE DECISION MADE: 04-MAY-06
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
DADE BEHRING, INC. 510(k) NO: K060502(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
P.O. BOX 6101 SE DECISION MADE: 18-MAY-06
M/S 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION TACR CALIBRATOR, MODEL DC107
DADE BEHRING, INC. 510(k) NO: K060503(TRADITIONAL)
ATTN: YUK-TING LEWIS PHONE NO : 302-631-7626
P.O. BOX 6101 SE DECISION MADE: 18-MAY-06
M/S 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO T
DADE BEHRING, INC. 510(k) NO: K061020(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
BLDG 500; M.S. 514 SE DECISION MADE: 10-MAY-06
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGE
DADE BEHRING, INC. 510(k) NO: K061238(SPECIAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
P.O. BOX 6101 SE DECISION MADE: 25-MAY-06
M/S 514 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K061251(TRADITIONAL)
ATTN: LORRAINE H PIESTRAK PHONE NO : 302-631-6279
BLDG 500; M.S. 514 SE DECISION MADE: 31-MAY-06
P.O. BOX 6101 510(k) SUMMARY AVAILABLE FROM FDA
NEWARK, DE 19714-6101
DEVICE: ELLIPSE 12PL, MODEL 9ESL7228
DANISH DERMATOLOGIC DEVELOPMENT A/510(k) NO: K060516(ABBREVIATED)
ATTN: OLE KOFOD PHONE NO : 454 576 8808
AGERN ALLE 11 SE DECISION MADE: 15-MAY-06
HOERSHOLM, DENMARK DK-2970 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TURKOM-CERA
DENTAL SUPPLIERS OF AMERICA, INC. 510(k) NO: K060860(TRADITIONAL)
ATTN: DAN WATSON PHONE NO : 360-474-9882
18616 123RD. AVENUE NE SE DECISION MADE: 19-MAY-06
ARLINGTON, WA 98223 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ABSOANCHOR MICROIMPLANT
DENTOS INC. 510(k) NO: K060126(TRADITIONAL)
ATTN: ANNA SHAFTO PHONE NO : 734-763-5758
1011 N. UNIVERSITY AVENUE SE DECISION MADE: 16-MAY-06
ANN ARBOR, MI 48109 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPFX ESTHETIC PROVISIONAL SYSTEM
DENTSPLY INTERNATIONAL, INC. 510(k) NO: K061264(SPECIAL)
ATTN: HELEN LEWIS PHONE NO : 717-845-7511
221 W. PHILADELPHIA ST., SE 60 SE DECISION MADE: 23-MAY-06
SUSQUEHANNA COMMERCE CTR. 510(k) SUMMARY AVAILABLE FROM FDA
YORK, PA 17404
DEVICE: SPIRALOK ANCHOR
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K060271(TRADITIONAL)
ATTN: RUTH FORSTADT PHONE NO : 508-977-3988
325 PARAMONT DRIVE SE DECISION MADE: 04-MAY-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP
DEPUY MITEK, A JOHNSON & JOHNSON C510(k) NO: K060553(SPECIAL)
ATTN: KRISTINE CHRISTO PHONE NO : 508-828-3359
325 PARAMONT DRIVE SE DECISION MADE: 04-MAY-06
RAYNHAM, MA 02767 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DEPUY SOLUTION SYSTEM HIP PROSTHESIS
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060581(SPECIAL)
ATTN: ANNE M SCHULER PHONE NO : 574-372-7098
700 ORTHOPAEDIC DR. SE DECISION MADE: 19-MAY-06
P.O. BOX 988 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0988
DEVICE: MEMORY STAPLE
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060746(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 25-MAY-06
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POLYAX LOCKED PLATING SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K060969(TRADITIONAL)
ATTN: RHONDA MYER PHONE NO : 574-371-4927
700 ORTHOPAEDIC DR. SE DECISION MADE: 12-MAY-06
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STA-CEPHASCREEN KIT
DIAGNOSTICA STAGO, INC. 510(k) NO: K053111(TRADITIONAL)
ATTN: JIM BARROW PHONE NO : 973-631-1200
5 CENTURY DR. SE DECISION MADE: 04-MAY-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DVTCARE CA5
DOCTORS ORDERS 510(k) NO: K061125(TRADITIONAL)
ATTN: JERRY KULAS PHONE NO : 616-931-9939
731 B CONSTRUCTION CT. SE DECISION MADE: 23-MAY-06
ZEELAND, MI 49464 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
DUCKWORTH & KENT, LTD. 510(k) NO: K060995(TRADITIONAL)
ATTN: MARTIN LOCK PHONE NO : 011 441 462893254
7 MARQUIS BUSINESS CENTRE SE DECISION MADE: 22-MAY-06
ROYSTON RD. 510(k) STATEMENT
BALDOCK, HERTFORDSHIRE, UNITED KINGDOM SG7 6XL
DEVICE: EAGLEVISION GELLANSERTS, MODEL REF 0040
EAGLE VISION, INC. 510(k) NO: K053333(TRADITIONAL)
ATTN: JEFF COBB PHONE NO : 901-380-7000
8500 WOLF LAKE DR. SE DECISION MADE: 02-MAY-06
SUITE 110 510(k) SUMMARY AVAILABLE FROM FDA
MEMPHIS, TN 38133
DEVICE: EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
EBI, L.P. 510(k) NO: K061098(TRADITIONAL)
ATTN: JENNIFER P HARAKAL PHONE NO : 973-299-9300
100 INTERPACE PKWY. SE DECISION MADE: 24-MAY-06
PARSIPPANY, NJ 07054 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BACSTOP
ELCAM MEDICAL A.C.A.L. 510(k) NO: K053405(TRADITIONAL)
ATTN: TALI HAZAN PHONE NO : 972 469 88875
KIBBUTZ BAR-AM SE DECISION MADE: 11-MAY-06
D.N. MEROM HAGALIL, ISRAEL 13860 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ESTECH AORTIC EASY FLOW CANNULA
ENDOSCOPIC TECHNOLOGIES, INC. 510(k) NO: K060101(TRADITIONAL)
ATTN: CRAIG COOMBS PHONE NO : 510-337-0140
1193 SHERMAN STREET SE DECISION MADE: 10-MAY-06
ALAMEDA, CA 94501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENPATH MEDICAL STEERABLE SHEATH
ENPATH MEDICAL, INC. 510(k) NO: K061119(SPECIAL)
ATTN: JAMES JENKINS PHONE NO : 763-577-2258
15301 HWY. 55 WEST SE DECISION MADE: 18-MAY-06
MINNEAPOLIS, MN 55447 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSURE II
ENTERIX INC. 510(k) NO: K060930(SPECIAL)
ATTN: EDWIN DIAZ PHONE NO : 732-429-1899
236 FERNWOOD AVE. SE DECISION MADE: 04-MAY-06
EDISON, NJ 08837 510(k) STATEMENT
DEVICE: MYLAB30, 50, 70 AND 90 SYSTEMS ADDITION OF 3D/4D, MODELS 7300, 7
ESAOTE, S.P.A. 510(k) NO: K060827(TRADITIONAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 19-MAY-06
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-M
ESAOTE, S.P.A. 510(k) NO: K060956(SPECIAL)
ATTN: CARRI GRAHAM PHONE NO : 317-569-9500
11460 N MERIDIAN ST., STE 150 SE DECISION MADE: 04-MAY-06
CARMEL, IN 46032 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOSHAPE
ETGAR GROUP H.M.Y.A. LTD. 510(k) NO: K060928(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 097 665 613
37A ROTHSCHILD ST., 44449 SE DECISION MADE: 22-MAY-06
KFAR-SABA, ISRAEL 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROCEED SURGICAL MESH
ETHICON INC. 510(k) NO: K060713(TRADITIONAL)
ATTN: SERGIO J GADALETA PHONE NO : 908-218-3102
ROUTE 22 WEST SE DECISION MADE: 25-MAY-06
PO BOX 151 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: EUROMED SURESKIN III WITH SILVER WOUND DRESSINGS
EUROMED, INC. 510(k) NO: K050032(TRADITIONAL)
ATTN: MARY MCNAMARA-CULLINANE PHONE NO : 508-643-0434
49 PLAIN ST. SE DECISION MADE: 17-MAY-06
NORTH ATTLEBORO, MA 02760 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC VINYL PATIENT EXAMINATION GLOVE-POWERED
EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K060784(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 01-MAY-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVE-POWDER FREE
EVER LIGHT PLASTIC PRODUCTS CO., L510(k) NO: K060786(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 08-MAY-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AN
FISHER DIAGNOSTICS 510(k) NO: K052308(TRADITIONAL)
ATTN: M. HEATHER CAMERON PHONE NO : 540-869-8163
8365 VALLEY PIKE SE DECISION MADE: 10-MAY-06
MIDDLETOWN, VA 22645-0307 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, M
FOXHOLLOW TECHNOLOGIES, INC. 510(k) NO: K061063(SPECIAL)
ATTN: MELISSA MURPHY PHONE NO : 650-421-8579
740 BAY ST. SE DECISION MADE: 18-MAY-06
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRIPOD
FREEDOM DESIGNS, INC. 510(k) NO: K060926(TRADITIONAL)
ATTN: BOB GARDNER PHONE NO : 805-582-0077
2241 MADERA RD. SE DECISION MADE: 19-MAY-06
SIMI VALLEY, CA 93065 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARCHITECT BNP ASSAY, MODEL 8K28
FUJIREBIO DIAGNOSTICS, INC. 510(k) NO: K060964(TRADITIONAL)
ATTN: DIANA L WOLANIUK PHONE NO : 610-240-3917
201 GREAT VALLEY PKWY. SE DECISION MADE: 25-MAY-06
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FUTURE MOBILITY HEALTHCARE INC. ORION II WHEELCHAIR AND STELLATO
FUTURE MOBILITY HEALTHCARE INC. 510(k) NO: K061010(TRADITIONAL)
ATTN: WILLIAM SALTER PHONE NO : 905 671 1661
2775 SLOUGH STR SE DECISION MADE: 23-MAY-06
MISSISSAUGA, ON, CANADA L4T 1G2 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: G.USBAMP
G.TEC MEDICAL ENGINEERING GMBH 510(k) NO: K060803(TRADITIONAL)
ATTN: CHRISTOPH GUGER PHONE NO : 725 122 24012
SIERNINGSTRASSE 14 SE DECISION MADE: 02-MAY-06
SCHIEDLBERG, AUSTRIA 4521 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L
GE HEALTHCARE 510(k) NO: K061185(SPECIAL)
ATTN: JOEL KENT PHONE NO : 781-449-8685
86 PILGRIM ROAD SE DECISION MADE: 15-MAY-06
NEEDHAM, MA 02492 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIQ FUSION
GE HEALTHCARE 510(k) NO: K061370(TRADITIONAL)
ATTN: LARRY A KROGER PHONE NO : 262-544-3894
3000 N. GRANDVIEW BLVD. SE DECISION MADE: 30-MAY-06
MAILSTOP W-440 510(k) SUMMARY AVAILABLE FROM FDA
WAUKESHA, WI 53188 THIRD PARTY REVIEW
DEVICE: CENTRICITY AW SUITE OPTION
GE HEALTHCARE INFORMATION TECHNOLO510(k) NO: K061372(TRADITIONAL)
ATTN: RHODA VALERA PHONE NO : 847-277-6092
540 W. NW HIGHWAY SE DECISION MADE: 30-MAY-06
BARRINGTON, IL 60010 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: GE LOGIQ P5 AND A5
GENERAL ELECTRIC CO. 510(k) NO: K060993(SPECIAL)
ATTN: ALLEN SCHUH PHONE NO : 414-721-3992
P.O. BOX 414 SE DECISION MADE: 03-MAY-06
MILWAUKEE, WI 53201 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GIVEN DIAGNOSTIC SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K053639(TRADITIONAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 011 972 49097784
NEW INDUSTRIAL PARK SE DECISION MADE: 08-MAY-06
P.O. BOX 258 510(k) SUMMARY AVAILABLE FROM FDA
YOQNEAM, ISRAEL 20692
DEVICE: MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
GIVEN IMAGING LTD. 510(k) NO: K060805(SPECIAL)
ATTN: SHOSHANA FRIEDMAN PHONE NO : 011 972 49097784
SHAAR YOKNEAM SE DECISION MADE: 24-MAY-06
NEW INDUSTRIAL ZONE, 510(k) SUMMARY AVAILABLE FROM FDA
YOKNEAM (P.O.BOX 258), ISRAEL 20692
DEVICE: XPAND RADIOLUCENT CORPECTOMY SPACER
GLOBUS MEDICAL INC. 510(k) NO: K060665(SPECIAL)
ATTN: KELLY J BAKER PHONE NO : 610-415-9000
303 SCHELL LN. SE DECISION MADE: 10-MAY-06
PHOENIXVILLE, PA 19460 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPEECHLINK 100 TYPE 1053
GN OTOMETRICS A/S 510(k) NO: K061104(TRADITIONAL)
ATTN: PER PAPE THOMSEN PHONE NO : 45 721 11555
DYBENDALSVAENGET 2 SE DECISION MADE: 03-MAY-06
P.O. BOX 119 510(k) SUMMARY AVAILABLE FROM FDA
TAASTRUP, DENMARK DK-2630 THIRD PARTY REVIEW
DEVICE: HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
GUIDANT CORPORATION 510(k) NO: K060449(TRADITIONAL)
ATTN: JENNIFER PAE RIGGS PHONE NO : 951-914-4581
26531 YNEZ ROAD SE DECISION MADE: 30-MAY-06
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HAEMONETICS 40U RBC FILTER BAG
HAEMONETICS CORP. 510(k) NO: K061103(TRADITIONAL)
ATTN: GABRIEL J MURACA PHONE NO : 781-356-9553
400 WOOD RD. SE DECISION MADE: 17-MAY-06
P.O. BOX 9114 510(k) SUMMARY AVAILABLE FROM FDA
BRAINTREE, MA 02184 THIRD PARTY REVIEW
DEVICE: DEPILITE EL-8B SERIES DERMO FLASH SYSTEMS
HAIR INTERNATIONAL SYSTEMS USA, IN510(k) NO: K052371(TRADITIONAL)
ATTN: CRAIG A MITCHELL PHONE NO : 949-250-9066
4590 MACARTHER BLVD., STE. 500 SE DECISION MADE: 04-MAY-06
NEWPORT BEACH, CA 92692-2028 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROBERTSITE STOPCOCK
HALKEY-ROBERTS CORP. 510(k) NO: K061143(TRADITIONAL)
ATTN: RADAMES PIERANTONI PHONE NO : 727-577-1300
11600 M.L. KING BLVD.,NORTH SE DECISION MADE: 10-MAY-06
ST. PETERSBURG, FL 33716 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K060352(TRADITIONAL)
ATTN: JACK SPEER PHONE NO : 801-773-2529
FREEPORT CENTER BLDG E-13 DR 2 SE DECISION MADE: 31-MAY-06
PO BOX 160435 510(k) SUMMARY AVAILABLE FROM FDA
CLEARFIELD, UT 84016-0435
DEVICE: ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
HELENA LABORATORIES 510(k) NO: K061014(SPECIAL)
ATTN: PATRICIA FRANKS PHONE NO : 409-842-3714
1530 LINDBERGH DR. SE DECISION MADE: 10-MAY-06
P.O. BOX 752 510(k) SUMMARY AVAILABLE FROM FDA
BEAUMONT, TX 77704-0752
DEVICE: MONDIAL
HERAEUS KULZER, INC. 510(k) NO: K060994(TRADITIONAL)
ATTN: CHERYL V ZIMMERMAN PHONE NO : 574-299-6662
4315 SOUTH LAFAYETTE BLVD. SE DECISION MADE: 22-MAY-06
SOUTH BEND, IN 46614 510(k) STATEMENT
DEVICE: HOMMED CENTRAL STATION, VERSION 3.5
HONEYWELL HOMMED LLC 510(k) NO: K053453(TRADITIONAL)
ATTN: TOMMIE J MORGAN PHONE NO : 713-880-5111
2018 NORTH DURHAM DRIVE SE DECISION MADE: 05-MAY-06
HOUSTON, TX 77008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGICAL FACE MASK
HONG YA NON-WOVEN PRODUCTS CO., LT510(k) NO: K060776(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE. SE DECISION MADE: 25-MAY-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXSOS PLUS LOCKING PLATE SYSTEM
HOWMEDICA OSTEONICS CORP. 510(k) NO: K061012(TRADITIONAL)
ATTN: FRANCISCO HARO PHONE NO : 201-831-5493
325 CORPORATE DRIVE SE DECISION MADE: 19-MAY-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCES
HOYA CONBIO, INC 510(k) NO: K060977(TRADITIONAL)
ATTN: LIZA BURNS PHONE NO : 209-586-0416
19722 WESTVIEW DRIVE SE DECISION MADE: 24-MAY-06
TWAIN HARTE, CA 95373 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALPHASPHERE ORBITAL IMPLANT
HYDRON PTY LIMITED 510(k) NO: K053298(TRADITIONAL)
ATTN: JUDY F GORDON PHONE NO : 949-715-0609
733 BOLSANA DRIVE SE DECISION MADE: 09-MAY-06
LAGUNA BEACH, CA 92651 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6
HYPHEN BIOMED 510(k) NO: K050367(TRADITIONAL)
ATTN: OLA ANDERSON PHONE NO : 513-770-1993
6560 GOVE CT. SE DECISION MADE: 24-MAY-06
MASON, OH 45040 510(k) STATEMENT
DEVICE: IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
IMMCO DIAGNOSTICS, INC. 510(k) NO: K060157(TRADITIONAL)
ATTN: KEVIN LAWSON PHONE NO : 716-691-0091
60 PINEVIEW DR. SE DECISION MADE: 25-MAY-06
BUFFALO, NY 14228-2120 510(k) STATEMENT
DEVICE: LEGACY ABUTMENT SYSTEM
IMPLANT DIRECT LLC 510(k) NO: K060063(TRADITIONAL)
ATTN: ROSEMARIE MASTELLER PHONE NO : 818-444-3323
27030 MALIBU HILLS RD. SE DECISION MADE: 19-MAY-06
CALABASAS HILLS, CA 91301 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PROVIDE TEMPORARY CYLINDER
IMPLANT INNOVATIONS, INC. 510(k) NO: K061177(SPECIAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932
4555 RIVERSIDE DR. SE DECISION MADE: 16-MAY-06
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LE
INNOVA VISION INC. 510(k) NO: K053191(SPECIAL)
ATTN: JENNIFER REICH PHONE NO : 928-773-9488
2904 N. BOLDT DRIVE SE DECISION MADE: 12-MAY-06
FLAGGSTAFF, AZ 86001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IGS VAGINAL SPECULUM
INNOVATIVE GYNECOLOGICAL SOLUTIONS510(k) NO: K060129(TRADITIONAL)
ATTN: JOSEPH P PAOLO PHONE NO : 603-880-1433
5 WENTWORTH DRIVE SE DECISION MADE: 04-MAY-06
HUDSON, NH 03051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSPIRSTAR GLOVE ELECTRODE
INSPIRSTAR, INC. 510(k) NO: K061343(TRADITIONAL)
ATTN: NING WU PHONE NO : 480-634-8708
891 N. NAPLES DR. SE DECISION MADE: 31-MAY-06
CHANDLER, AZ 85226 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HEMOSIL PT-FIBRINOGEN HS PLUS
INSTRUMENTATION LABORATORY CO. 510(k) NO: K060931(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 02-MAY-06
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LICOX IT2 COMPLETE BRAIN TUNNELING PROBE KIT
INTEGRA LIFESCIENCES CORP. 510(k) NO: K053244(SPECIAL)
ATTN: JON CAPAROTTA PHONE NO : 609-936-2495
311 ENTERPRISE DRIVE SE DECISION MADE: 10-MAY-06
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DPOAE20 , ECLIPSE
INTERACOUSTICS A/S, ASSENS 510(k) NO: K060539(TRADITIONAL)
ATTN: DANIEL EGGAN PHONE NO : 952-278-4457
7625 GOLDEN TRIANGLE DRIVE SE DECISION MADE: 30-MAY-06
EDEN PRAIRIE, MN 55344 510(k) STATEMENT
DEVICE: INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 40021
INTUITIVE SURGICAL, INC. 510(k) NO: K061260(SPECIAL)
ATTN: MICHAEL H YRAMATEGUI PHONE NO : 408-523-2100
950 KIFER RD. SE DECISION MADE: 18-MAY-06
SUNNYVALE, CA 94086-5206 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1
IRIDEX CORP. 510(k) NO: K060905(TRADITIONAL)
ATTN: JOHN JOSSY PHONE NO : 650-962-8848
1212 TERRA BELLA AVE. SE DECISION MADE: 31-MAY-06
MOUNTAIN VIEW, CA 94043 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
IVES EEG SOLUTIONS, INC. 510(k) NO: K060189(TRADITIONAL)
ATTN: JOHN IVES PHONE NO : 613 692 1567
6325 RIDEAU VALLEY DRIVE SE DECISION MADE: 30-MAY-06
MANOTICK, ONTARIO, CANADA K4M 1B3 510(k) STATEMENT
DEVICE: CONDYLAFORM II NFC
IVOCLAR VIVADENT, INC. 510(k) NO: K060565(TRADITIONAL)
ATTN: DONNA M HARTNETT PHONE NO : 716-691-0010
175 PINEVIEW DR. SE DECISION MADE: 08-MAY-06
AMHERST, NY 14228 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
JIANGSU EVERYGUARD PLASTIC PRODUCT510(k) NO: K060909(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
RM 1606 BLDG 1JIANZIANG YUAN SE DECISION MADE: 24-MAY-06
NO 209 BEI SI HUAN SHONG RD HA 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, CHINA 100083
DEVICE: INFREX
JOHARI DIGITAL HEALTHCARE LTD. 510(k) NO: K060246(TRADITIONAL)
ATTN: POOJA JOHARI PHONE NO : 818 888 8520
7131 FARRALONE AVE, #48, SE DECISION MADE: 05-MAY-06
CANOGA PARK, CA 91303 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: JUNIPER COOLING DEVICE
JUNIPER MEDICAL TECHNOLOGY, INC 510(k) NO: K060407(TRADITIONAL)
ATTN: ROSEMARY HARRY PHONE NO : 206-390-5583
7139 KOLL PARKWAY SUITE 300 SE DECISION MADE: 31-MAY-06
PLEASANTON, CA 94566 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: K-JUMP DIGITAL THERMOMETER WITH BATTERY-LESS PATCH, MODEL KD-210
K-JUMP HEALTH CO., LTD. 510(k) NO: K060240(ABBREVIATED)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORHTERN BLVD. SE DECISION MADE: 19-MAY-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DENALI DEFORMITY SYSTEM
K2M, LLC 510(k) NO: K052404(TRADITIONAL)
ATTN: RICHARD W WOODS PHONE NO : 703-777-3155
751 MILLER DRIVE SE, SUITE F1 SE DECISION MADE: 23-MAY-06
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PYRENEES CERVICAL PLATE SYSTEM
K2M, LLC 510(k) NO: K060442(TRADITIONAL)
ATTN: RICH WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 15-MAY-06
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VANTAGE INDIRECT OPHTHALMOSCOPE
KEELER INSTRUMENTS, INC. 510(k) NO: K060822(SPECIAL)
ATTN: EUGENE R VANARSDALE PHONE NO : 610-353-4350
456 PKWY. SE DECISION MADE: 23-MAY-06
BROOMALL, PA 19008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOBLANKET SURGICAL MESH
KENSEY NASH CORPORATION 510(k) NO: K061030(SPECIAL)
ATTN: DEBORAH RACIOPPI PHONE NO : 610-594-4389
735 PENNSYLVANIA DRIVE SE DECISION MADE: 09-MAY-06
EXTON, PA 19341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KIMBERLY-CLARK IMPERVIOUS COMFORT GOWN
KIMBERLY-CLARK CORP. 510(k) NO: K052824(TRADITIONAL)
ATTN: CHERYL M SANZARE PHONE NO : 770-587-7131
1400 HOLCOMB BRIDGE RD. SE DECISION MADE: 02-MAY-06
ROSWELL, GA 30076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANCHOR PLUS/NEO ANCHOR PLUS
KJ MEDITECH 510(k) NO: K053629(TRADITIONAL)
ATTN: CHARLIE MACK PHONE NO : 931-937-8093
340 SHADY GROVE ROAD SE DECISION MADE: 31-MAY-06
FLINTVILLE, TN 37335 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KONICA MINOLTA PULSOX-300, 300I
KONICA MINOLTA SENSING, INC. 510(k) NO: K053419(TRADITIONAL)
ATTN: NANCI DEXTER PHONE NO : 303-359-9791
2703 JOSEPHINE ST. SE DECISION MADE: 11-MAY-06
DENVER, CO 80205 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE,WHITE (NON-COLORED
KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K060771(TRADITIONAL)
ATTN: LIM K HWA PHONE NO : 603 339 27616
LOT 16632, 5-1/4 MILES, SE DECISION MADE: 01-MAY-06
JALAN MERU 510(k) STATEMENT
KLANG, SELANGOR, MALAYSIA 41050
DEVICE: POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PRO
KOSSAN LATEX INDUSTRIES (M) SDN. B510(k) NO: K060775(TRADITIONAL)
ATTN: LIM K HWA PHONE NO : 603 339 27616
LOT 16632, 5-1/4 MILES, SE DECISION MADE: 16-MAY-06
JALAN MERU 510(k) STATEMENT
KELANG, SELANGOR, MALAYSIA 41050
DEVICE: EYE SEE MULTIPURPOSE, NO-RUB CONTACT LENS SOLUTION
LAPIS LAZULI, NV 510(k) NO: K051104(TRADITIONAL)
ATTN: MARTIN DALSING PHONE NO : 970-243-5490
623 GLACIER DRIVE SE DECISION MADE: 31-MAY-06
GRAND JUNCTION, CO 81503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LIFE SPINE CEMENT RESTRICTOR
LIFE SPINE 510(k) NO: K060247(TRADITIONAL)
ATTN: ERIN MALLOY PHONE NO : 847-884-6117
2400 HASSELL ROAD SE DECISION MADE: 11-MAY-06
SUITE 370 510(k) SUMMARY AVAILABLE FROM FDA
HOFFMAN ESTATES, IL 60195
DEVICE: SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD
LIFECORE BIOMEDICAL, INC. 510(k) NO: K060530(TRADITIONAL)
ATTN: RACHEL KENNEDY PHONE NO : 952-368-4300
3515 LYMAN BLVD. SE DECISION MADE: 22-MAY-06
CHASKA, MN 55318 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC. 510(k) NO: K061118(SPECIAL)
ATTN: MARY ELLEN HOLDEN PHONE NO : 408-942-3589
1000 GIBRALTAR DR. SE DECISION MADE: 19-MAY-06
MILPITAS, CA 95035-6312 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPR
LINVATEC CORP. 510(k) NO: K060198(SPECIAL)
ATTN: ELIZABETH PAUL PHONE NO : 727-399-5234
11311 CONCEPT BLVD. SE DECISION MADE: 11-MAY-06
LARGO, FL 33773-4908 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MANI NEEDLE & SUTURE PACK (NYLON)
MANI, INC. 510(k) NO: K053637(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209
1301K STREET, N.W. SE DECISION MADE: 19-MAY-06
SUITE 1100 - EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005-3373
DEVICE: MANI NEEDLE & SUTURE PACK (SILK)
MANI, INC. 510(k) NO: K053638(TRADITIONAL)
ATTN: DAVID J BLOCH PHONE NO : 202-414-9209
1301K STREET, N.W. SE DECISION MADE: 19-MAY-06
SUITE 1100 - EAST TOWER 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20005-3373
DEVICE: ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
MAQUET CARDIOPULMONARY AG 510(k) NO: K061072(TRADITIONAL)
ATTN: KATRIN SCHWENKGIENKS PHONE NO : 011 497 4789210
HECHINGER STRASSE 38 SE DECISION MADE: 23-MAY-06
HIRRLINGEN, GERMANY 72145 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3MATIC
MATERIALISE N.V. 510(k) NO: K060950(TRADITIONAL)
ATTN: CARL VAN LIERDE PHONE NO : 32 163 96714
15 TECHNOLOGIELAAN SE DECISION MADE: 18-MAY-06
LEUVEN, BELGIUM 3001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AVANZA
MDS NORDION 510(k) NO: K060870(TRADITIONAL)
ATTN: ROSS KACHANIWSKY PHONE NO : 613 592 3400
447 MARCH RD. SE DECISION MADE: 15-MAY-06
OTTAWA, ONTARIO, CANADA K2K1X8 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC AD
MEASUREMENT SPECIALTIES, INC. 510(k) NO: K061191(SPECIAL)
ATTN: KRISTA OAKES PHONE NO : 972-849-5167
2300 MCDERMOTT ROAD SE DECISION MADE: 22-MAY-06
# 200-207 510(k) SUMMARY AVAILABLE FROM FDA
PLANO, TX 75025
DEVICE: SWING
MEDELA AG 510(k) NO: K053052(TRADITIONAL)
ATTN: WEMER FREI PHONE NO : +41 417 695151
LAETTICHSTRASSE 4B SE DECISION MADE: 02-MAY-06
BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)
MEDICULT A/S 510(k) NO: K060699(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 10-MAY-06
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SONOACE PICO DIAGNOSTIC ULTRASOUND SYSTEM
MEDISON CO., LTD. 510(k) NO: K061213(TRADITIONAL)
ATTN: SHIM KYUNG-AM PHONE NO : 82 2 21941381
1003, DAECHI-DONG SE DECISION MADE: 16-MAY-06
GANGNAM-GU 510(k) SUMMARY AVAILABLE FROM FDA
SEOUL, REPUBLIC OF KOREA 135-280 THIRD PARTY REVIEW
DEVICE: CONTACT LENS OPHTHALMODYNAMOMETER
MEDITRON, GMBH 510(k) NO: K052674(TRADITIONAL)
ATTN: ROBERT N CLARK PHONE NO : 303-234-9412
13605 W. 7TH AVE. SE DECISION MADE: 24-MAY-06
GOLDEN, CO 80401-4604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO MEDRAD CONTINUUM MR INFUSION SYSTEM
MEDRAD, INC. 510(k) NO: K061128(SPECIAL)
ATTN: JOHN M KISTE PHONE NO : 412-767-2400
ONE MEDRAD DR. SE DECISION MADE: 22-MAY-06
INDIANOLA, PA 15051 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDTOX OCYCODONE
MEDTOX DIAGNOSTICS, INC. 510(k) NO: K060351(TRADITIONAL)
ATTN: PHILLIP HARTZOG PHONE NO : 336-226-6311
1238 ANTHONY RD. SE DECISION MADE: 12-MAY-06
BURLINGTON, NC 27215 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTURE ANTERIOR CERVICAL PLATE SYSTEM
MEDTRONIC SOFAMOR DANEK 510(k) NO: K061274(SPECIAL)
ATTN: RICHARD TREHAME PHONE NO : 901-396-3133
1800 PYRAMID PLACE SE DECISION MADE: 25-MAY-06
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
MEDTRONIC, INC. 510(k) NO: K061127(SPECIAL)
ATTN: PHIL NEURURER PHONE NO : 763-514-2875
8299 CENTRAL AVENUE N.E. SE DECISION MADE: 23-MAY-06
MINNEAPOLIS, MN 55432 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
MERITS HEALTH PRODUCTS CO., LTD. 510(k) NO: K053230(TRADITIONAL)
ATTN: STEVE CHAO PHONE NO : 886 423 694986X240
9, ROAD 36 SE DECISION MADE: 16-MAY-06
TAICHUNG INDUSTRIAL PARK 510(k) SUMMARY AVAILABLE FROM FDA
TAICHUNG, CHINA (TAIWAN) 407
DEVICE: SONICATOR 730, MODEL ME 730
METTLER ELECTRONICS CORP. 510(k) NO: K053546(ABBREVIATED)
ATTN: ROBERT E FLEMING PHONE NO : 714-533-2221
1333 SOUTH CLAUDINA ST. SE DECISION MADE: 04-MAY-06
ANAHEIM, CA 92805 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CARDIOIMMUNE XL CARDIAC MARKER CONTROL
MICROGENICS CORP. 510(k) NO: K061196(TRADITIONAL)
ATTN: SCOTT HUNTSMAN PHONE NO : 510-979-5169
46360 FREMONT BLVD. SE DECISION MADE: 30-MAY-06
FREMONT, CA 94538 510(k) STATEMENT
DEVICE: MICROTEK MEDICAL WARMING DRAPE
MICROTEK MEDICAL, INC. 510(k) NO: K060200(TRADITIONAL)
ATTN: THOMAS BONNER PHONE NO : 662-327-1863
512 LEHMBERG RD. SE DECISION MADE: 31-MAY-06
COLUMBUS, MS 39702 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICRUS COURIER MICROCATHETERS
MICRUS ENDOVASCULAR CORPORATION 510(k) NO: K060116(TRADITIONAL)
ATTN: MARGARET WEBBER PHONE NO : 408-433-1408
821 FOX LANE SE DECISION MADE: 12-MAY-06
SAN JOSE, CA 95131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIDIVIEW SERIES OF MICROENDOSCOPES
MILLENNIUM DEVICES, INC. 510(k) NO: K051073(TRADITIONAL)
ATTN: JOSEPH LIBRIZZI PHONE NO : 631-582-8440
250 GIBBS RD. SE DECISION MADE: 17-MAY-06
ISLANDIA, NY 11749-2697 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIM 4.0 (NEURO
MIMVISTA CORP. 510(k) NO: K060816(TRADITIONAL)
ATTN: PETER SIMMELINK PHONE NO : 216-896-9798
25200 CHAGRIN BLVD. SUITE 200 SE DECISION MADE: 16-MAY-06
CLEVELAND, OH 44122 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MORTARA SURVEYOR TELEMETRY CENTRAL STATION
MORTARA INSTRUMENT, INC. 510(k) NO: K060135(ABBREVIATED)
ATTN: HARLAN L VAN MATRE PHONE NO : 414-354-1600
7865 NORTH 86TH ST. SE DECISION MADE: 15-MAY-06
MILWAUKEE, WI 53224-3431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORAMAGIC PLUS ORAL WOUND RINSE
MPM MEDICAL, INC. 510(k) NO: K060340(TRADITIONAL)
ATTN: RICHARD A HAMER PHONE NO : 248-808-3612
897 CHANCERY CT SE DECISION MADE: 10-MAY-06
MONROE, MI 48161 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEP SPLINT
NAKAGAWA DENTAL CLINIC 510(k) NO: K060122(TRADITIONAL)
ATTN: MAKI SAKURABA PHONE NO : 516-742-6705
225 FIRST STREET SE DECISION MADE: 19-MAY-06
MINEOLA, NY 11501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRABECTOME HIGH FREQUENCY GENERATOR/LP
NEOMEDIX CORP. 510(k) NO: K061258(TRADITIONAL)
ATTN: THOMAS SCHROEDER PHONE NO : 714-290-5720
15042 PARKWAY LOOP SE DECISION MADE: 18-MAY-06
SUITE A 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92780 THIRD PARTY REVIEW
DEVICE: MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035
NEUSOFT MEDICAL SYSTEMS CO., LTD. 510(k) NO: K061132(SPECIAL)
ATTN: TIAN YANFANG PHONE NO : 86 24 83660649
NO.3-11, WENHUA ROAD SE DECISION MADE: 24-MAY-06
HEPING DISTRICT 510(k) SUMMARY AVAILABLE FROM FDA
SHENYANG, LIAONING, CHINA 110004
DEVICE: TTC PLATE
NEWDEAL S.A. 510(k) NO: K060473(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 17-MAY-06
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPIDUS PLATE
NEWDEAL S.A. 510(k) NO: K060476(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 17-MAY-06
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXA CARPO METACARPAL IMPLANT
NEXA ORTHOPEDICS, INC. 510(k) NO: K060386(TRADITIONAL)
ATTN: LOUISE M FOCHT PHONE NO : 858-866-0660
10675 SORRENTO VALLEY ROAD SE DECISION MADE: 10-MAY-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92121
DEVICE: CARDIOFAX CE, MODEL ECG-1500 A
NIHON KOHDEN AMERICA, INC. 510(k) NO: K052511(TRADITIONAL)
ATTN: SERRAH NAMINI PHONE NO : 949-580-1555
90 ICON ST. SE DECISION MADE: 24-MAY-06
FOOTHILL RANCH, CA 92610-1601 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NODECREST TRANSCRANICAL DOPPLER ULTRASOUND SYSTEM
NODECREST LLC 510(k) NO: K060112(TRADITIONAL)
ATTN: E. J SMITH PHONE NO : 410-451-0639
1676 VILLAGE GREEN, SUITE A SE DECISION MADE: 05-MAY-06
CORFTON, MD 21114 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200
NOVA ORTHO-MED, INC. 510(k) NO: K061273(TRADITIONAL)
ATTN: SUE CHEN PHONE NO : 310-352-3600
345 WEST VICTORIA ST. SE DECISION MADE: 23-MAY-06
GARDENA, CA 90248 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
NOVABONE PRODUCTS, LLC 510(k) NO: K060728(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 01-MAY-06
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPY INTRAOPERATIVE IMAGING SYSTEM
NOVADAQ TECHNOLOGIES, INC. 510(k) NO: K060867(TRADITIONAL)
ATTN: ALLISON MANNERS PHONE NO : 905 629 3822 X 240
2585 SKYMARK AVENUE, STE. 306 SE DECISION MADE: 03-MAY-06
MISSISSAUGA, ONTARIO, CANADA L4W 4510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LAPARO-THORACO VIDEOSCOPE XLTF-VAW
OLYMPUS AMERICA, INC. 510(k) NO: K053382(TRADITIONAL)
ATTN: TRACY GULSEN PHONE NO : 631-844-5529
PO BOX 9058 SE DECISION MADE: 26-MAY-06
MELVILLE, NY 11747-9058 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
OMRON HEALTHCARE, INC. 510(k) NO: K060811(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 317-335-3780
6329 W. WATERVIEW CT. SE DECISION MADE: 25-MAY-06
MCCORDSVILLE, IN 46055-9501 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MUCHECK V7.0
ONCOLOGY DATA SYSTEMS, INC. 510(k) NO: K061152(TRADITIONAL)
ATTN: GREG MILLER PHONE NO : 405-680-5222
1601 SW 89TH STREET SE DECISION MADE: 10-MAY-06
BUILDING E-100 510(k) SUMMARY AVAILABLE FROM FDA
OKLAHOMA CITY, OK 73159 THIRD PARTY REVIEW
DEVICE: PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
ONSET MEDICAL CORPORATION 510(k) NO: K061009(SPECIAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ SUITE 312 SE DECISION MADE: 02-MAY-06
MISSION VIEJO, CA 92691 510(k) STATEMENT
DEVICE: OPTYSE OPHTHALMOSCOPE
OPHTHALMOS LTD. 510(k) NO: K061278(ABBREVIATED)
ATTN: LAURA J GARCIA PHONE NO : 440 179 9532777
UNIT 1 ABBEY BARNS SE DECISION MADE: 16-MAY-06
DUXFORD ROAD 510(k) SUMMARY AVAILABLE FROM FDA
ICKLETON, CAMBRIDGE, UNITED KINGDOTHIRD PARTY REVIEW
DEVICE: CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE
ORIDION CAPNOGRAPHY, INC. 510(k) NO: K060065(TRADITIONAL)
ATTN: SANFORD BROWN PHONE NO : 972 2 5899115
HAR HOTZVIM SCI BASED IND PK SE DECISION MADE: 04-MAY-06
POB 45025 510(k) SUMMARY AVAILABLE FROM FDA
JERUSALEM, ISRAEL 91450
DEVICE: SENSOR WALK
OTTO BOCK HEALTH CARE, LP 510(k) NO: K052771(TRADITIONAL)
ATTN: BILL CLOVER PHONE NO : 763-489-5142
2 CARLSON PWY. STE. 100 SE DECISION MADE: 03-MAY-06
MINNEAPOLIS, MN 55447-4467 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5
OXLIFE LLC 510(k) NO: K060922(SPECIAL)
ATTN: MARGARET K POTEAT PHONE NO : 828-684-7353
141 TWIN SPRINGS RD. SE DECISION MADE: 30-MAY-06
HENDERSONVILLE, NC 28792 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGMA ALPHA VAPORIZER
PENLON LIMITED 510(k) NO: K060331(TRADITIONAL)
ATTN: BARRY PEARCE PHONE NO : 001 441 235547000
25 BARKER CLOSE SE DECISION MADE: 10-MAY-06
FISHBOURNE, CHICHESTER 510(k) SUMMARY AVAILABLE FROM FDA
WEST SUSSEX, UNITED KINGDOM PO18 8BJ
DEVICE: EG-3670URK
PENTAX MEDICAL COMPANY 510(k) NO: K061068(TRADITIONAL)
ATTN: PAUL SILVA PHONE NO : 800-431-5880
102 CHESTNUT RIDGE RD. SE DECISION MADE: 03-MAY-06
MONTVALE, NJ 07645-1856 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CEMENT-IT ALL PURPOSE, MODEL N97
PENTRON CLINICAL TECHNOLOGIES 510(k) NO: K060698(TRADITIONAL)
ATTN: GREG MOREAU PHONE NO : 203-265-7397
68-70 NORTH PLAINS INDUSTRIAL SE DECISION MADE: 10-MAY-06
ROAD 510(k) SUMMARY AVAILABLE FROM FDA
WALLINGFORD, CT 06492
DEVICE: THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,M
PHILIPS MEDICAL SYSTEMS NORTH AMER510(k) NO: K061052(SPECIAL)
ATTN: HAUKE SCHIK PHONE NO : 497 031 4632031
HEWLETT-PACKARD-STR. 2 SE DECISION MADE: 26-MAY-06
BOEBLINGEN, GERMANY D-71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QLAB QUANTIFICATION SOFTWARE
PHILIPS ULTRASOUND, INC. 510(k) NO: K061396(TRADITIONAL)
ATTN: LYNN HARMER PHONE NO : 425-487-7312
22100 BOTHELL EVERETT HWY. SE DECISION MADE: 30-MAY-06
P.O. BOX 3003 510(k) SUMMARY AVAILABLE FROM FDA
BOTHELL, WA 98041 THIRD PARTY REVIEW
DEVICE: CATHASSIST
PHYSICIAN TECHNOLOGIES, INC. 510(k) NO: K052952(TRADITIONAL)
ATTN: RANDALL MAY PHONE NO : 714-612-1870
4932 EAST HOLBROOK STREET SE DECISION MADE: 14-MAY-06
ANAHEIM, CA 92807-1154 510(k) STATEMENT
DEVICE: PLAYTEX SPORT PLASTIC, PLAYTEX SPORT PLASTIC MULTIPACK TAMPONS
PLAYTEX PRODUCTS, INC. 510(k) NO: K060981(SPECIAL)
ATTN: KEITH EDGETT PHONE NO : 302-678-6880
75 COMMERCE DR. SE DECISION MADE: 09-MAY-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRYOCHECK CLOT APCR
PRECISION BIOLOGIC INC. 510(k) NO: K060284(TRADITIONAL)
ATTN: STEPHEN L DUFF PHONE NO : 902 468 6422 X224
900 WINDMILL RD., SUITE 100 SE DECISION MADE: 10-MAY-06
DARTMOUTH, N.S., CANADA B3B 1P7 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AUTOMOBILE LIGHTER POWER CORD
PULMONETIC SYSTEMS, INC. 510(k) NO: K060549(TRADITIONAL)
ATTN: ROBERT C SAMEC PHONE NO : 762-398-8305
117400 MEDINA RD. SE DECISION MADE: 04-MAY-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447-1341
DEVICE: LTV 1200 VENTILATOR
PULMONETIC SYSTEMS, INC. 510(k) NO: K060647(TRADITIONAL)
ATTN: ROBERT SAMEC PHONE NO : 763-398-8305
17400 MEDINA ROAD SE DECISION MADE: 25-MAY-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MINNEAPOLIS, MN 55447
DEVICE: PSL PORTABLE SLIT LAMP
REICHERT, INC. 510(k) NO: K061330(ABBREVIATED)
ATTN: SANDRA BROWN PHONE NO : 716-686-4599
3374 WALDEN AVE. SE DECISION MADE: 25-MAY-06
DEPEW, NY 14043 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: REMA SHAVER BLADES
REMA MEDIZINTECHNIK GMBH. 510(k) NO: K060172(TRADITIONAL)
ATTN: GERALD GOIGITZER PHONE NO : 954-217-8780
731-733 SHOTGUN ROAD SE DECISION MADE: 31-MAY-06
FT. LAUDERDALE, FL 33326 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100
RENAL SOLUTIONS, INC. 510(k) NO: K060381(SPECIAL)
ATTN: DAVID J VANELLA PHONE NO : 724-772-6900
770 COMMONWEALTH DR. SE DECISION MADE: 24-MAY-06
WARRENDALE, PA 15086 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000
RESONANCE INNOVATIONS LLC 510(k) NO: K061170(SPECIAL)
ATTN: RANDALL JONES PHONE NO : 402-934-2650
12530 HARNEY CIRCLE SE DECISION MADE: 25-MAY-06
OMAHA, NE 68154 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RHYTHMLINK DISC ELECTRODES
RHYTHMLINK INTERNATIONAL, LLC 510(k) NO: K061148(TRADITIONAL)
ATTN: JAMES W MEWBORNE PHONE NO : 803-252-1222
1256 FIRST ST. SOUTH EXTENSION SE DECISION MADE: 10-MAY-06
COLUMBIA, SC 29209 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: RS-1000 ZOOM SLITLAMP WITH OPTION
RIGHTMEDICAL PRODUCTS, LLC 510(k) NO: K060869(TRADITIONAL)
ATTN: HARUMI KUMAHARA PHONE NO : 757-963-7064
200 EXPRESSWAY COURT SE DECISION MADE: 11-MAY-06
VIRGINIA BEACH, VA 23462 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060585(TRADITIONAL)
ATTN: RANDY JOHNSON PHONE NO : 317-521-3532
9115 HAGUE RD. SE DECISION MADE: 03-MAY-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ENZYME IMMUNOASSAY, VANCOMYCIN
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060586(TRADITIONAL)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 11-MAY-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATI
ROCHE DIAGNOSTICS CORP. 510(k) NO: K060645(ABBREVIATED)
ATTN: DIMITRIS DEMIRTZOGLOU PHONE NO : 317-521-7688
9115 HAGUE RD. SE DECISION MADE: 30-MAY-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
ROCHE DIAGNOSTICS CORP. 510(k) NO: K061048(SPECIAL)
ATTN: CORINA HARPER PHONE NO : 317-521-3831
9115 HAGUE RD. SE DECISION MADE: 17-MAY-06
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PIEZOTOME
SATELEC 510(k) NO: K060274(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 856-222-9888
130 GAITHER DRIVE SE DECISION MADE: 01-MAY-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: PIEZOTOME
SATELEC 510(k) NO: K060275(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 856-222-9988
130 GAITHER DRIVE SE DECISION MADE: 03-MAY-06
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSA
SAUFLON PHARMACEUTICALS, LTD. 510(k) NO: K052832(TRADITIONAL)
ATTN: TANYA FAIR PHONE NO : +44 208 3224231
49-53 YORK ST. SE DECISION MADE: 15-MAY-06
TWICKENHAM, MIDDLESEX, UNITED KING510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ARGUS, MODEL LCM
SCHILLER AG 510(k) NO: K053207(TRADITIONAL)
ATTN: MARKUS BUETLER PHONE NO : 417 664 252
ALTGASSE 68 SE DECISION MADE: 19-MAY-06
BAAR, ZG, SWITZERLAND 6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIO 1-KIT BIOSORB FILLED CARTRIDGE
SCIENCE FOR BIOMATERIALS 510(k) NO: K061022(TRADITIONAL)
ATTN: DENIS CLEMENT PHONE NO : 335 624 22101
ZI DU MONGE SE DECISION MADE: 24-MAY-06
LOURDES, FRANCE 65100 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BREATH ALCOHOL TEST SYSTEM, MODEL AL-6000
SENTECH KOREA CORP. 510(k) NO: K060343(TRADITIONAL)
ATTN: MATTHEW H SON PHONE NO : 201-943-9411
21 GRAND AVE. SUITE 103 SE DECISION MADE: 11-MAY-06
PALISADES PARK, NJ 07650 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LA
SHEN WEI (USA), INC. 510(k) NO: K060073(TRADITIONAL)
ATTN: CYNTHIA LIU PHONE NO : 510-429-8692
33278 CENTRAL AVE., SE DECISION MADE: 01-MAY-06
SUITE 102 510(k) STATEMENT
UNION CITY, CA 94587
DEVICE: PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K053193(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN - FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 18-MAY-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PM-9000 EXPRESS PATIENT MONITOR
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K053234(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 04-MAY-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
SHENZHEN MINDRAY BIO-MEDICAL ELECT510(k) NO: K060949(SPECIAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 480-451-7502
55 NORTHERN BLVD., SUITE 200 SE DECISION MADE: 04-MAY-06
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AXIOM ARISTOS FX PLUS
SIEMENS MEDICAL SOLUTIONS USA INC.510(k) NO: K061054(SPECIAL)
ATTN: GARY JOHNSON PHONE NO : 601-448-1778
51 VALLEY STREAM PARKWAY SE DECISION MADE: 09-MAY-06
E-50 510(k) SUMMARY AVAILABLE FROM FDA
MALVERN, PA 19355
DEVICE: COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPAC
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K060633(TRADITIONAL)
ATTN: CHRISTINE DUNBAR PHONE NO : 925-602-8139
4040 NELSON AVE. SE DECISION MADE: 01-MAY-06
CONCORD, CA 94520 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OR HEAD COIL 1.5 T
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K060758(TRADITIONAL)
ATTN: JUDITH CAMPBELL PHONE NO : 610-448-4918
51 VALLEY STREAM PKWY. SE DECISION MADE: 05-MAY-06
MALVERN, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SINCLAIR ORAL RINSE
SINCLAIR PHARMACEUTICALS LIMITED 510(k) NO: K053166(TRADITIONAL)
ATTN: MICHAEL KILLEEN PHONE NO : 972 478 4380
BOROUGH ROAD SE DECISION MADE: 17-MAY-06
GODALMING, SURREY, UNITED KINGDOM 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MO
SLEEPNET CORP. 510(k) NO: K060273(TRADITIONAL)
ATTN: PAUL CHIESA PHONE NO : 603-624-1911
1050 PERIMETER RD. SE DECISION MADE: 02-MAY-06
MANCHESTER AIR CENTER 510(k) SUMMARY AVAILABLE FROM FDA
MANCHESTER, NH 03103
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE (BLACK AND GRAY)
SMART GLOVE CORP. SDN BHD 510(k) NO: K060724(TRADITIONAL)
ATTN: CHO SOW FONG PHONE NO : 603 329 16100
BATU 5 3/4, JALAN KAPAR SE DECISION MADE: 17-MAY-06
KLANG 510(k) STATEMENT
SELANGOR DARUL ESHAN, MALAYSIA 42100
DEVICE: POWDER FREE NITRILE EXAMINATION GLOVE COATED WITH CUCUMBER WITH
SMART GLOVE CORP. SDN BHD 510(k) NO: K060726(TRADITIONAL)
ATTN: CHO SOW FONG PHONE NO : 603 329 16100
BATU 5 3/4, JALAN KAPAR SE DECISION MADE: 25-MAY-06
KLANG 510(k) STATEMENT
SELANGOR DARUL ESHAN, MALAYSIA 42100
DEVICE: LEGION COBALT CHROME REVISION KNEE SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K060742(SPECIAL)
ATTN: JASON SELLS PHONE NO : 901-399-5520
1450 BROOKS RD. SE DECISION MADE: 03-MAY-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFLECTION 3 ACETABULAR SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K061253(SPECIAL)
ATTN: KATIE LOGEROT PHONE NO : 901-399-5778
1450 BROOKS RD. SE DECISION MADE: 31-MAY-06
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PORT IMPLANTABLE
SMITHS MEDICAL MD, INC. 510(k) NO: K060036(TRADITIONAL)
ATTN: MELANIE HESS PHONE NO : 651-628-7333
1265 GREY FOX RD. SE DECISION MADE: 17-MAY-06
ST. PAUL, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLARIS I310D INTRAORAL CAMERA SYSTEM & ACCESSORIES
SOTA PRECISION OPTICS, INC. 510(k) NO: K061175(SPECIAL)
ATTN: JAY MANSOUR PHONE NO : 678-908-8180
845 ARONSON LAKE COURT SE DECISION MADE: 23-MAY-06
ROSWELL, GA 30075 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT
SPECIALEYES LLC 510(k) NO: K060821(TRADITIONAL)
ATTN: ARTHUR WARD PHONE NO : 813-645-2855
962 ALLEGRO LANE SE DECISION MADE: 18-MAY-06
APOLLO BEACH, FL 33572 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 15.5FR DECATHLON COATED TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER
SPIRE BIOMEDICAL, INC. 510(k) NO: K060155(TRADITIONAL)
ATTN: DONALD FICKETT PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 09-MAY-06
BEDFORD, MA 01730-2396 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODE
STEREOTAXIS, INC. 510(k) NO: K051760(TRADITIONAL)
ATTN: PETER A TAKES PHONE NO : 314-615-6940
4041 FOREST PARK AVE. SE DECISION MADE: 05-MAY-06
ST. LOUIS, MO 63108 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: REPROCESSED ENDOSCOPIC TROCAR
STERILMED, INC. 510(k) NO: K052299(TRADITIONAL)
ATTN: THOMAS A DOLD PHONE NO : 763-488-3410
11400 73RD AVE. NORTH, #100 SE DECISION MADE: 23-MAY-06
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REPROCESSED BALOON INFLATION DEVICE
STERILMED, INC. 510(k) NO: K053188(TRADITIONAL)
ATTN: BRUCE R LESTER PHONE NO : 888-856-4870
11400 73RD AVE. NORTH, #100 SE DECISION MADE: 04-MAY-06
MAPLE GROVE, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HIPSTAR FEMORAL STEM
STRYKER ORTHOPAEDICS 510(k) NO: K051223(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5412
325 CORPORATE DRIVE SE DECISION MADE: 10-MAY-06
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM
STRYKER SPINE 510(k) NO: K060506(TRADITIONAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 25-MAY-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XIA TITANIUM AND 4.5 SPINAL SYSTEMS
STRYKER SPINE 510(k) NO: K060979(SPECIAL)
ATTN: SIMONA VOIC PHONE NO : 201-760-8145
2 PEARL COURT SE DECISION MADE: 19-MAY-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS
SURETEK MEDICAL 510(k) NO: K052690(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 864-281-9302
44 BELLWOOD FARMS SE DECISION MADE: 12-MAY-06
GREENVILLE, SC 29607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
SURETEK MEDICAL 510(k) NO: K052691(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 864-281-9302
44 BELLWOOD FARMS SE DECISION MADE: 17-MAY-06
GREENVILLE, SC 29607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES
SURETEK MEDICAL 510(k) NO: K052692(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 864-281-9302
44 BELLWOOD FARMS SE DECISION MADE: 10-MAY-06
GREENVILLE, SC 29607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURETEK MEDICAL REPROCESSED ARTHROSCOPIC BLADES AND BURS
SURETEK MEDICAL 510(k) NO: K052695(TRADITIONAL)
ATTN: MIKE SAMMON PHONE NO : 864-281-9302
44 BELLWOOD FARMS SE DECISION MADE: 10-MAY-06
GREENVILLE, SC 29607 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE COLOUR POWDER FREE BARRIERPRO POLYMER BP2000 POLYBUTADIENE
SYNTEX HEALTHCARE PRODUCTS CO. LTD510(k) NO: K061192(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAFER AVE. SE DECISION MADE: 23-MAY-06
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
SYSMEX AMERICA, INC. 510(k) NO: K060656(TRADITIONAL)
ATTN: NINA GAMPERLING PHONE NO : 847-996-4675
ONE NELSON C. WHITE PARKWAY SE DECISION MADE: 10-MAY-06
MUNDELEIN, IL 60060 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPACER-S TEMPORARY SHOULDER SPACER
TECRES SPA 510(k) NO: K060535(TRADITIONAL)
ATTN: DIANE TAYLOR PHONE NO : 352-377-1140
2320 N.W. 66TH COURT SE DECISION MADE: 24-MAY-06
GAINSVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COSMATRIX
TEI BIOSCIENCES INC. 510(k) NO: K060829(ABBREVIATED)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 17-MAY-06
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: XENFORM SOFT TISSUE REPAIR MATRIX
TEI BIOSCIENCES INC. 510(k) NO: K060984(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 17-MAY-06
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TISSUEMEND SOFT TISSUE REPAIR MATRIX
TEI BIOSCIENCES INC. 510(k) NO: K060989(SPECIAL)
ATTN: KENNETH JAMES PHONE NO : 617-268-1616
7 ELKINS ST. SE DECISION MADE: 15-MAY-06
BOSTON, MA 02127 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRODUCER ASSEMBLY WITH ROTATOR LOCK
TELEFLEX MEDICAL 510(k) NO: K060519(SPECIAL)
ATTN: LORI HAYS PHONE NO : 847-572-8027
2345 WAUKEGAN ROAD SE DECISION MADE: 05-MAY-06
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
BANNOCKBURN, IL 60015
DEVICE: DEKNA-LOK MODEL BP1000V2L
TELEFLEX MEDICAL 510(k) NO: K060801(TRADITIONAL)
ATTN: KIMBERLY EDGERTON PHONE NO : 919-361-3957
2917 WECK DRIVE SE DECISION MADE: 17-MAY-06
RESEARCH TRIANGLE PARK, NC 27709 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUARIUSAPS SERVER
TERARECON, INC. 510(k) NO: K061214(TRADITIONAL)
ATTN: EMILLY TOJIMA PHONE NO : 650-653-4313
2955 CAMPUS DR., SUITE 325 SE DECISION MADE: 15-MAY-06
SAN MATEO, CA 94403 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BABYBEAT CORDLESS
THE NEWMAN GROUP, LLC 510(k) NO: K061091(TRADITIONAL)
ATTN: SPENCER NEWMAN PHONE NO : 312-455-9808
935 WEST CHESTNUT ST. SE DECISION MADE: 04-MAY-06
SUITE 430 510(k) STATEMENT
CHICAGO, IL 60622 THIRD PARTY REVIEW
DEVICE: VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
THERALIGHT, INC. 510(k) NO: K061295(SPECIAL)
ATTN: KEVIN E DALY PHONE NO : 760-930-8000
2794 LOKER AVE. WEST,SUITE 105 SE DECISION MADE: 25-MAY-06
CARLSBAD, CA 92010 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-22
THERATECH, INC. 510(k) NO: K060975(SPECIAL)
ATTN: MICHAEL PRICE PHONE NO : 615-865-4000
1109 MYATT BLVD. SE DECISION MADE: 10-MAY-06
MADISON, TN 37115 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TINNITUS PHASE-OUT
TINNITUS CONTROL, INC. 510(k) NO: K061111(SPECIAL)
ATTN: RUSS PAGANO PHONE NO : 202-546-1262
719 A STREET, NE SE DECISION MADE: 16-MAY-06
WASHINGTON, DC 20002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: REFA, PHYSIOLOGICAL AMPLIFIER
TMS INTERNATIONAL BV 510(k) NO: K060374(ABBREVIATED)
ATTN: DAVID W WAGNER PHONE NO : 303-674-3070
7744 SWAPS TRAIL SE DECISION MADE: 30-MAY-06
EVERGREEN, CO 80439 510(k) STATEMENT
DEVICE: TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING
TOSHIBA AMERICA MEDICAL SYSTEMS, I510(k) NO: K061187(TRADITIONAL)
ATTN: PAUL BIGGINS PHONE NO : 714-730-5000
2441 MICHELLE DR. SE DECISION MADE: 12-MAY-06
P.O. BOX 2068 510(k) SUMMARY AVAILABLE FROM FDA
TUSTIN, CA 92781-2068 THIRD PARTY REVIEW
DEVICE: 15-INCH (38CM) COLOR LCD MONITOR CDL1566A
TOTOKU ELECTRIC CO., LTD 510(k) NO: K060961(TRADITIONAL)
ATTN: MIKIO HASEGAWA PHONE NO : 812 683 45469
300 OYA SE DECISION MADE: 01-MAY-06
UEDA, NAGANO, JAPAN 386-0192 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUSCEPTIBILITY TEST PLATE FOR VANCOMYCIN VRSA LIMITATION REMOVAL
TREK DIAGNOSTIC SYSTEMS, INC. 510(k) NO: K060783(TRADITIONAL)
ATTN: CYNTHIA C KNAPP PHONE NO : 800-871-8909
982 KEYNOTE CIRCLE SUITE 6 SE DECISION MADE: 16-MAY-06
CLEVELAND, OH 44131 510(k) STATEMENT
DEVICE: GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000
TYCO HEALTHCARE GROUP, LP 510(k) NO: K060649(TRADITIONAL)
ATTN: KEITH MARTIN PHONE NO : 508-261-8440
15 HAMPSHIRE ST. SE DECISION MADE: 22-MAY-06
MANSFIELD, MA 02048 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARBLUE EASY DIGITAL PREGNANCY TEST
UNIPATH LTD. 510(k) NO: K060128(TRADITIONAL)
ATTN: LOUISE ROBERTS PHONE NO : 44 123 4835564
PRIORY BUSINESS PARK SE DECISION MADE: 25-MAY-06
BEDFORD, UNITED KINGDOM MK44 3UP 510(k) STATEMENT
DEVICE: DSNARE DIMINUTIVE POLYPECTOMY AND SUCTION SYSTEM, MODEL 00711087
UNITED STATES ENDOSCOPY GROUP, INC510(k) NO: K061201(SPECIAL)
ATTN: MICHAEL WOLF PHONE NO : 440-639-4494
5976 HEISELY RD. SE DECISION MADE: 30-MAY-06
MENTOR, OH 44060 510(k) STATEMENT
DEVICE: AUTO SUTUR ENDO GIA STAPLERS
UNITED STATES SURGICAL, A DIVISION510(k) NO: K061095(TRADITIONAL)
ATTN: FRANK GIANELLI PHONE NO : 203-492-5352
150 GLOVER AVE. SE DECISION MADE: 31-MAY-06
NORWALK, CT 06856 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: USGI TRANSPORT ENDOSCOPIC GUIDE
USGI MEDICAL 510(k) NO: K061216(SPECIAL)
ATTN: MARY LOU MOONEY PHONE NO : 949-369-3890
1140 CALLE CORDILLERA SE DECISION MADE: 15-MAY-06
SAN CLEMENTE, CA 92673 510(k) STATEMENT
DEVICE: HEMOHALT HEMOSTASIS PAD
VANSON-HALOSOURCE, INC. 510(k) NO: K060409(TRADITIONAL)
ATTN: ERIC ROBINSON PHONE NO : 425-974-1989
14716 NE 87TH ST. SE DECISION MADE: 17-MAY-06
REDMOND, WA 98052 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRILOGY RADIOTHERAPY DELIVERY SYSTEM
VARIAN MEDICAL SYSTEMS 510(k) NO: K061140(TRADITIONAL)
ATTN: VY TRAN PHONE NO : 650-424-5731
3100 HANSEN WAY SE DECISION MADE: 15-MAY-06
PALO ALTO, CA 94304-1129 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IG4 IMAGE GUIDED SYSTEM
VERAN MEDICAL TECHNOLOGIES, INC. 510(k) NO: K060903(TRADITIONAL)
ATTN: TORSTEN M LYON PHONE NO : 303-594-3666
2409 21ST AVENUE SOUTH SE DECISION MADE: 11-MAY-06
SUITE 205 510(k) SUMMARY AVAILABLE FROM FDA
NASHVILLE, TN 37212
DEVICE: VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
VISION BIOSYSTEMS INC. 510(k) NO: K060227(ABBREVIATED)
ATTN: RON LAGERQUIST PHONE NO : 800-753-7264
700 LONGWATER DRIVE SE DECISION MADE: 25-MAY-06
NORWELL, MA 02061 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OMI RETRACTABLE SAFETY SYRINGE
VITALCARE GROUP, INC. 510(k) NO: K060109(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
P.O. BOX 7007 SE DECISION MADE: 05-MAY-06
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO REBILDA DC
VOCO GMBH 510(k) NO: K060893(SPECIAL)
ATTN: MICHAEL SUS PHONE NO : 490 472 1719214
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 25-MAY-06
CUXHAVEN, GERMANY D-27472 510(k) STATEMENT
DEVICE: BIFIX QM
VOCO GMBH 510(k) NO: K060894(SPECIAL)
ATTN: MICHAEL SUS PHONE NO : 490 472 1719214
ANTON-FLETTNER-STRASSE 1-3 SE DECISION MADE: 02-MAY-06
CUXHAVEN, GERMANY D-27472 510(k) STATEMENT
DEVICE: DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM
W & H DENTALWERK BUERMOOS GMBH 510(k) NO: K060287(TRADITIONAL)
ATTN: GABRIELE WIENBECK PHONE NO : 011 436 2746236397
IGNAZ GLASER STR. 53 SE DECISION MADE: 03-MAY-06
BUERMOOS, AUSTRIA A-5111 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 40 L HIGH FLOW INSUFFLATOR F113
W.O.M. WORLD OF MEDICINE AG 510(k) NO: K060723(TRADITIONAL)
ATTN: SUSANNE RAAB PHONE NO : 202-390-8227
1490 CAMBRIDGE STREET SE DECISION MADE: 25-MAY-06
CAMBRIDGE, MA 02139 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
WEI FANG JIUZHOU GLOVES CO., LTD. 510(k) NO: K060884(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
209 BEI SI HUAN ZHONG RD., SE DECISION MADE: 04-MAY-06
R. 106 BLDG. 1 JIANXIANG YUAN 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, HAIDIAN DISTRIC, CHINA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
WEI FANG JIUZHOU GLOVES CO., LTD. 510(k) NO: K060886(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 861 082 387441
209 BEI SI HUAN ZHONG RD., SE DECISION MADE: 04-MAY-06
R. 106 BLDG. 1 JIANXIANG YUAN 510(k) SUMMARY AVAILABLE FROM FDA
BEIJING, HAIDIAN DISTRIC, CHINA
DEVICE: KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCES
WFR/AQUAPLAST CORP. 510(k) NO: K060671(TRADITIONAL)
ATTN: J. DAMON KIRK PHONE NO : 201-891-1042
30 LAWLINS PARK SE DECISION MADE: 04-MAY-06
WYCKOFF, NJ 07481 510(k) STATEMENT
DEVICE: PROFEMUR TL HIP STEM
WRIGHT MEDICAL TECHNOLOGY, INC. 510(k) NO: K060358(SPECIAL)
ATTN: MATT PAUL PHONE NO : 901-867-4350
5677 AIRLINE RD. SE DECISION MADE: 10-MAY-06
ARLINGTON, TN 38002 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA
ZIMMER DENTAL INC. 510(k) NO: K060880(SPECIAL)
ATTN: WILLIAM FISHER PHONE NO : 760-929-4166
1900 ASTON AVE. SE DECISION MADE: 17-MAY-06
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TRABECULAR METAL ACETABULAR AUGMENTS
ZIMMER TRABECULAR 510(k) NO: K061067(TRADITIONAL)
ATTN: ROBERT A POGGIE PHONE NO : 201-818-1800
80 COMMERCE DR. SE DECISION MADE: 25-MAY-06
ALLENDALE, NJ 07401 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER M/L TAPER HIP PROSTHESIS
ZIMMER, INC. 510(k) NO: K060040(SPECIAL)
ATTN: KAREN CAIN PHONE NO : 574-372-4219
P.O. BOX 708 SE DECISION MADE: 12-MAY-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 1
ZIMMER, INC. 510(k) NO: K060704(SPECIAL)
ATTN: DALENE T BINKLEY PHONE NO : 574-372-4907
P.O. BOX 708 SE DECISION MADE: 19-MAY-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEA
ZIMMER, INC. 510(k) NO: K060722(TRADITIONAL)
ATTN: BRANDON HIPSHER PHONE NO : 574-371-8083
P.O. BOX 708 SE DECISION MADE: 26-MAY-06
WARSAW, IN 46581-0708 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 298
TOTAL WITH SUMMARIES 257
TOTAL WITH STATEMENTS 41
Updated June 5, 2006
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