SUBMITTER ADDRESS LISTING FOR CDRH SUBSTANTIALLY EQUIVALENT (SE)
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD 01-FEB-2007 THROUGH 28-FEB-2007
DEVICE: 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1
3M COMPANY 510(k) NO: K063023(ABBREVIATED)
ATTN: DIANNE GIBBS PHONE NO : 651-737-9117
3M CENTER BUILDING 275-05W-06 SE DECISION MADE: 23-FEB-07
ST. PAUL, MN 55144 510(k) STATEMENT
DEVICE: STARCLOSE HEX-HUB DILATOR
ABBOTT VASCULAR INC. 510(k) NO: K062554(TRADITIONAL)
ATTN: DAUN PUTNAM PHONE NO : 650-474-3323
400 SAGINAW DR. SE DECISION MADE: 06-FEB-07
REDWOOD CITY, CA 94063 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACON DIGITAL THERMOMETER PROBE COVERS
ACON LABORATORIES, INC. 510(k) NO: K063418(TRADITIONAL)
ATTN: JINN-NAN LIN, PH.D PHONE NO : 858-875-8028
4108 SORRENTO VALLEY BLVD. SE DECISION MADE: 02-FEB-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLASSIC/HYPOTHERMIA, FLEXIBLE, 10-SECOND, LEFT-RIGHT HANDED, BAS
ACTHERM, INC. 510(k) NO: K070028(SPECIAL)
ATTN: RICHARD HSIEH PHONE NO : 886 3 5537315
6TH F., #85 KUAN-MIN 6 RD. SE DECISION MADE: 08-FEB-07
JUBEI, HSINCHU, CHINA (TAIWAN) 302510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AN
ACUMEN MEDICAL, INC. 510(k) NO: K070197(SPECIAL)
ATTN: MARYBETH GAMBER PHONE NO : 408-530-1810
275 SANTA ANA COURT SE DECISION MADE: 23-FEB-07
SUNNYVALE, CA 94085 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROLUX TRANSILLUMINATOR
ADDENT, INC. 510(k) NO: K062961(TRADITIONAL)
ATTN: JOSHUA FRIEDMAN PHONE NO : 203-778-0200
43 MIRY BROOK RD. SE DECISION MADE: 08-FEB-07
DANBURY, CT 06810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM
AESCULAP, INC. 510(k) NO: K062012(TRADITIONAL)
ATTN: LISA M BOYLE PHONE NO : 610-797-9300
3773 CORPORATE PKWY. SE DECISION MADE: 09-FEB-07
CENTER VALLEY, PA 18034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
AGA MEDICAL CORP. 510(k) NO: K070238(TRADITIONAL)
ATTN: DAVID D COX PHONE NO : 763-531-3064
682 MENDELSSOHN AVE. SE DECISION MADE: 28-FEB-07
PLYMOUTH, MN 55427 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EUSOL-C
AL.CHIM. 510(k) NO: K063617(SPECIAL)
ATTN: GEORGE MYERS PHONE NO : 201-727-1703
377 ROUTE 17 S SE DECISION MADE: 08-FEB-07
HASBROUCK HEIGHTS, NJ 07604 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXSEPT WC WOUND CLEANSER
ALCAVIS INTERNATIONAL, INC. 510(k) NO: K061467(TRADITIONAL)
ATTN: GARY J MISHKIN PHONE NO : 301-330-7597
8322 HELGERMAN COURT SE DECISION MADE: 15-FEB-07
GAITHERSBURG, MD 20877 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: QUATTRO CATHETER MODEL IC4593
ALSIUS CORP. 510(k) NO: K070161(TRADITIONAL)
ATTN: KENNETH A COLLINS PHONE NO : 949-453-0150
15770 LAGUNA CANYON, SUITE 150 SE DECISION MADE: 15-FEB-07
IRVINE, CA 92618 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERAMILL ZI
AMANN GIRRBACH AMERICA, INC. 510(k) NO: K063511(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 02-FEB-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AMS SMART SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC. 510(k) NO: K063713(TRADITIONAL)
ATTN: BRAD ONSTAD PHONE NO : 952-933-6139
10700 BREN RD., WEST SE DECISION MADE: 22-FEB-07
MINNETONKA, MN 55343 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLUCO TRACK BLOOD GLUCOSE MONITORING SYSTEM
APEX BIOTECHNOLOGY CORP. 510(k) NO: K062799(TRADITIONAL)
ATTN: BRUCE A MACFARLANE PHONE NO : 952-646-3188
5182 WEST 76TH ST. SE DECISION MADE: 06-FEB-07
MINNEAPOLIS, MN 55439 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ASSURE 4 BLOOD GLUCOSE MONITORING SYSTEM
APEX BIOTECHNOLOGY CORP. 510(k) NO: K070088(SPECIAL)
ATTN: THOMAS Y.S. SHEN PHONE NO : 011 886 35641952
NO. 7, LI-HSIN ROAD V, SE DECISION MADE: 16-FEB-07
HSINCHU SCIENCE PARK 510(k) SUMMARY AVAILABLE FROM FDA
HSINCHU, CHINA (TAIWAN) 30078
DEVICE: ZIPPREP ELECTRODE
ASPECT MEDICAL SYSTEMS, INC. 510(k) NO: K070069(SPECIAL)
ATTN: VIKRAM VERMA PHONE NO : 617-559-7000
1 UPLAND ROAD SE DECISION MADE: 05-FEB-07
NORWOOD, MA 02062 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGIMESH WN
ASPIDE MEDICAL 510(k) NO: K061445(TRADITIONAL)
ATTN: HOWARD M HOLSTEIN PHONE NO : 202-637-5813
555 THIRTEENTH ST. NW SE DECISION MADE: 01-FEB-07
COLUMBIA SQUARE 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20004-1109
DEVICE: ATLANTIS ABUTMENT FOR 3I MICROMINI IMPLANT
ATLANTIS COMPONENTS, INC. 510(k) NO: K062069(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 14-FEB-07
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLANTIS ABUTMENT FOR 3I CERTAIN MICRO MINI; GEMINI AND GEMINI+
ATLANTIS COMPONENTS, INC. 510(k) NO: K062197(TRADITIONAL)
ATTN: BETSY A BROWN PHONE NO : 847-560-4406
8944 TAMAROA TERRACE SE DECISION MADE: 28-FEB-07
SKOKIE, IL 60076 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ATLAS SPINE VERTEBRAL BODY REPLACEMENT
ATLAS SPINE LLC 510(k) NO: K063205(TRADITIONAL)
ATTN: FLOYD G LARSON PHONE NO : 858-792-1235
11234 EL CAMINO REAL SE DECISION MADE: 26-FEB-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
SAN DIEGO, CA 92130
DEVICE: INFINITI SYSTEM
AUTOGENOMICS, INC 510(k) NO: K060564(TRADITIONAL)
ATTN: EVELYN LOPEZ PHONE NO : 949-248-9074
2251 RUTHERFORD ROAD SE DECISION MADE: 07-FEB-07
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,
BAXTERHEALTHCARE, INC. 510(k) NO: K063696(TRADITIONAL)
ATTN: JEME WALLACE PHONE NO : 847-473-6273
ONE BAXTER PARKWAY SE DECISION MADE: 27-FEB-07
DEERFIELD, IL 60015-4633 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTE
BECKMAN COULTER, INC. 510(k) NO: K070144(TRADITIONAL)
ATTN: TYLER J FOUTCH PHONE NO : 952-368-1653
1000 LAKE HAZELTINE DR. SE DECISION MADE: 01-FEB-07
CHASKA, MN 55318-1084 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32
BECTON, DICKINSON & CO. 510(k) NO: K063811(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 09-FEB-07
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64
BECTON, DICKINSON & CO. 510(k) NO: K063824(TRADITIONAL)
ATTN: JANINE MATLAK PHONE NO : 410-316-4938
7 LOVETON CIR. SE DECISION MADE: 14-FEB-07
SPARKS, MD 21152-0999 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
BEKS INCORPORATED 510(k) NO: K063704(TRADITIONAL)
ATTN: JILL CREASY PHONE NO : 630-480-0476
694 BLUFF STREET # 104 SE DECISION MADE: 20-FEB-07
CAROL STREAM, IL 60188 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PATHIAM IMAGING SOFTWARE FOR HER2/NEU
BIOLMAGENE, INC. 510(k) NO: K062756(TRADITIONAL)
ATTN: ANNA LONGWELL PHONE NO : 650-213-9162
1900 EMBARCADERO ROAD SE DECISION MADE: 20-FEB-07
SUITE 107 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94303
DEVICE: BIOMET TIBIAL LOCKING NAIL SYSTEM
BIOMET MANUFACTURING CORP. 510(k) NO: K063570(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
56 EAST BELL DRIVE SE DECISION MADE: 27-FEB-07
PO BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: ALTRA FX HIP SYSTEM
BIOMET MANUFACTURING CORP. 510(k) NO: K063614(TRADITIONAL)
ATTN: BECKY EARL PHONE NO : 574-267-6639
PO BOX 587 SE DECISION MADE: 20-FEB-07
WARSAW, IN 46581-0587 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR REP
BIOMET MANUFACTURING, INC. 510(k) NO: K063515(TRADITIONAL)
ATTN: SUSAN ALEXANDER PHONE NO : 574-267-6639
56 EAST BELL DR. SE DECISION MADE: 02-FEB-07
P.O. BOX 587 510(k) SUMMARY AVAILABLE FROM FDA
WARSAW, IN 46581-0587
DEVICE: RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
BIONIME CORPORATION 510(k) NO: K062567(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 516-482-9001
55 NORTHERN BLVD. SUITE 200 SE DECISION MADE: 16-FEB-07
GREAT NECK, NY 11021 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230
BIOSPACE CORPORATION LIMITED 510(k) NO: K062603(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-1727
PO BOX 7007 SE DECISION MADE: 15-FEB-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VERSATILE 1 EZCARE WOUND VACUUM SYSTEM
BLUE SKY MEDICAL GROUP INCORPORATE510(k) NO: K061919(TRADITIONAL)
ATTN: JASPER BENKE PHONE NO : 760-603-8130
5924 BALFOUR CT. SE DECISION MADE: 05-FEB-07
SUITE 102 510(k) SUMMARY AVAILABLE FROM FDA
CARLSBAD, CA 92008
DEVICE: BETA-POWDER
BRAINBASE CORPORATION 510(k) NO: K063236(TRADITIONAL)
ATTN: SATOSHI NOAKE PHONE NO : 81 3 37780745
YONEYAMA 2ND BLDG. 6F SE DECISION MADE: 16-FEB-07
22-13, OI 1-CHOME 510(k) SUMMARY AVAILABLE FROM FDA
SHINAGAWA-KU TOKYO, JAPAN 140-0014
DEVICE: ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
BRIGHT ELEMENT SDN BHD 510(k) NO: K063777(TRADITIONAL)
ATTN: SEOW LAW AUDIE PHONE NO : 603 339 28588
NO 5, JALAN USJ 3B/2 SE DECISION MADE: 23-FEB-07
SUBANG JAYA, SELANGOR, MALAYSIA 4510(k) STATEMENT
DEVICE: POSITIONER
C-RAD POSITIONING AB 510(k) NO: K063839(TRADITIONAL)
ATTN: BENGT ERIC ROSTH PHONE NO : 461 866 6930
KUNGSANGSVAGEN 29 SE DECISION MADE: 08-FEB-07
UPPSALA, SWEDEN 75323 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
C.R. BARD, INC. 510(k) NO: K063118(TRADITIONAL)
ATTN: SUSAN SCOTT PHONE NO : 801-595-0700
5425 WEST AMELIA EARHART DR. SE DECISION MADE: 13-FEB-07
SALT LAKE CITY, UT 84116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C.T.M. MOBILITY SCOOTER, MODEL HS-310
C.T.M. HOMECARE PRODUCT, INC. 510(k) NO: K070025(TRADITIONAL)
ATTN: LINDA J BOVARD PHONE NO : 541-345-5431
29611 SIMMONS ROAD SE DECISION MADE: 01-FEB-07
EUGENE, OR 97405 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CANDELA FLUORESCENT PULSED LIGHT SYSTEM
CANDELA CORP. 510(k) NO: K063800(TRADITIONAL)
ATTN: JEFFREY ROBERTS PHONE NO : 508-358-7400
530 BOSTON POST ROAD SE DECISION MADE: 05-FEB-07
WAYLAND, MA 01778 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
CARDINAL HEALTH 303, INC. 510(k) NO: K070268(SPECIAL)
ATTN: STACY L LEWIS PHONE NO : 858-458-7830
10221 WATERIDGE CIR. SE DECISION MADE: 23-FEB-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: C300 SERIES AIR NEBULIZER COMPRESSOR
CHOICE SMART HEALTH CARE COMPANY L510(k) NO: K062952(TRADITIONAL)
ATTN: JANICE MA PHONE NO : 86 21 63345066
2108 CIRO'S PLAZA SE DECISION MADE: 21-FEB-07
388 WEST NANJING ROAD 510(k) SUMMARY AVAILABLE FROM FDA
SHANGHAI, CHINA 200003 THIRD PARTY REVIEW
DEVICE: DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/O
COEUR, INC. 510(k) NO: K063114(ABBREVIATED)
ATTN: DEBRA F MANNING PHONE NO : 877-310-0351
704 CADET COURT SE DECISION MADE: 09-FEB-07
LEBANON, TN 37087 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: COLLAGEN MATRIX ANORGANIC BONE MINERAL BONE GRAFT MATERIALS
COLLAGEN MATRIX, INC. 510(k) NO: K062200(TRADITIONAL)
ATTN: PEGGY HANSON PHONE NO : 201-405-1477
509 COMMERCE ST. SE DECISION MADE: 13-FEB-07
FRANKLIN LAKES,, NJ 07417 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAODYN MAX PRESET, MODEL 4470
COMPEX TECHNOLOGIES, INC. 510(k) NO: K061516(TRADITIONAL)
ATTN: CARL BEAURLINE PHONE NO : 651-389-0771
1811 OLD HIGHWAY 8 SE DECISION MADE: 06-FEB-07
NEW BRIGHTON, MN 55112 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CORMATRIX PATCH FOR CARDIAC TISSUE REPAIR
CORMATRIX CARDIOVASCULAR, INC. 510(k) NO: K063349(TRADITIONAL)
ATTN: KIT CARIQUITAN PHONE NO : 408-400-0856
155 MOFFETT PARK DRIVE SE DECISION MADE: 16-FEB-07
SUITE A-101 510(k) SUMMARY AVAILABLE FROM FDA
SUNNYVALE, CA 94089
DEVICE: DURAFLEX
COSMETIC DENTAL MATERIALS INC 510(k) NO: K063626(TRADITIONAL)
ATTN: ROBERT BOWERS PHONE NO : 541-928-4444
812 WATER ST. N.E. SE DECISION MADE: 08-FEB-07
ALBANY, OR 97321 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CRITIVIEW, MODEL CRV3
CRITISENSE LTD. 510(k) NO: K062977(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. SE DECISION MADE: 28-FEB-07
# 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134-2015
DEVICE: DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR
DADE BEHRING, INC. 510(k) NO: K063425(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 15-FEB-07
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHL
DADE BEHRING, INC. 510(k) NO: K063564(TRADITIONAL)
ATTN: ROBERT EUSEBIO PHONE NO : 916-374-3183
2040 ENTERPRISE BLVD. SE DECISION MADE: 08-FEB-07
WEST SACRAMENTO, CA 95691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTE
DADE BEHRING, INC. 510(k) NO: K063608(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 23-FEB-07
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATO
DADE BEHRING, INC. 510(k) NO: K063655(TRADITIONAL)
ATTN: KATHLEEN DRAY-LYONS PHONE NO : 781-826-4551
P.O. BOX 6101 SE DECISION MADE: 15-FEB-07
NEWARK,, DE 19714 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CA
DADE BEHRING, INC. 510(k) NO: K063754(TRADITIONAL)
ATTN: PAMELA A JURGA PHONE NO : 302-631-8891
P.O. BOX 6101 BLDG 500;M.S.514 SE DECISION MADE: 23-FEB-07
NEWARK, DE 19714-6101 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0
DAILYCARE BIOMEDICAL INC 510(k) NO: K062894(TRADITIONAL)
ATTN: DANIEL J CHANG PHONE NO : 886 3 2621688
8F, 25-3 JI-LIN ROAD SE DECISION MADE: 08-FEB-07
CHUNGLI, CHINA (TAIWAN) 320 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX
DATASCOPE CORP. 510(k) NO: K062098(ABBREVIATED)
ATTN: KATHLEEN KRAMER PHONE NO : 201-995-8169
800 MACARTHUR BLVD. SE DECISION MADE: 05-FEB-07
MAHWAH, NJ 07430-0619 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING
DATASCOPE CORP. 510(k) NO: K062569(ABBREVIATED)
ATTN: SUSAN MANDY PHONE NO : 201-995-8758
1300 MACARTHUR BLVD SE DECISION MADE: 14-FEB-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLEARVIEW DENTAL HANDPIECE LUBRICATOR AND LUBRICANT
DENTAL AIR SOLUTIONS OF NC, INC. 510(k) NO: K070297(TRADITIONAL)
ATTN: THOMAS FEE PHONE NO : 919-771-7545
224 BRANCHSIDE LANE SE DECISION MADE: 05-FEB-07
HOLLY SPRINGS, NC 27540 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: DELTA XTEND REVERSE SHOULDER SYSTEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K062250(TRADITIONAL)
ATTN: NATALIE S HECK PHONE NO : 574-372-7469
700 ORTHOPAEDIC DR. SE DECISION MADE: 02-FEB-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GLOBAL AP POROUS COATED HUMERAL STEM
DEPUY ORTHOPAEDICS, INC. 510(k) NO: K063652(TRADITIONAL)
ATTN: REBECCA LENNARD PHONE NO : 574-371-4906
700 ORTHOPAEDIC DR. SE DECISION MADE: 01-FEB-07
WARSAW, IN 46581-0988 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DERMOTHERAP GUN
DERMOEQUIPOS S.R.L. 510(k) NO: K062339(TRADITIONAL)
ATTN: BENNY ARAZY PHONE NO : 972 4 99478800
MITZPE AVIV SE DECISION MADE: 05-FEB-07
INDUSTRIAL PARK 13 510(k) STATEMENT
M.P. MISGAV, ISRAEL 20187
DEVICE: DIASORIN LIAISON VZV IGG
DIASORIN, INC. 510(k) NO: K061820(TRADITIONAL)
ATTN: MARI MEYER PHONE NO : 651-351-5635
1951 NORTHWESTERN AVE. SE DECISION MADE: 26-FEB-07
P.O. BOX 285 510(k) SUMMARY AVAILABLE FROM FDA
STILLWATER, MN 55082
DEVICE: ACCU-CHEK ULTRAFLEX INFUSION SET
DISETRONIC MEDICAL SYSTEMS AG 510(k) NO: K070189(SPECIAL)
ATTN: MIKE FLIS PHONE NO : 317-521-2110
9115 HAGUE ROAD SE DECISION MADE: 21-FEB-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
DOCUSYS 510(k) NO: K062388(TRADITIONAL)
ATTN: GORDON J PETERS PHONE NO : 251-461-9903
820 SOUTH UNIVERSITY BLVD SE DECISION MADE: 22-FEB-07
SUITE 3-H 510(k) SUMMARY AVAILABLE FROM FDA
MOBILE, AL 36609
DEVICE: INFINITY TELESMART TELEMETRY SYSTEM
DRAEGER MEDICAL SYSTEMS, INC. 510(k) NO: K061379(TRADITIONAL)
ATTN: THOMAS M MCINTOSH PHONE NO : 978-907-7500
16 ELECTRONICS AVE. SE DECISION MADE: 16-FEB-07
DANVERS, MA 01923 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320
EIZO NANAO CORPORATION 510(k) NO: K070122(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 762 742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 08-FEB-07
HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS
EIZO NANAO CORPORATION 510(k) NO: K070131(SPECIAL)
ATTN: HIROAKI HASHIMOTO PHONE NO : 81 76 2742468
153 SHIMOKASHIWANO-CHO SE DECISION MADE: 15-FEB-07
HAKUSAN, ISHIKAWA-KEN, JAPAN 924-8510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DOWN PAK
ENDO TWINN B.V. 510(k) NO: K070246(SPECIAL)
ATTN: F.M. VERHOEVEN PHONE NO : 312 048 67571
DANZIGERKADE 17 SE DECISION MADE: 16-FEB-07
AMSTERDAM, NETHERLANDS 1013 AP 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM
ESSENTIAL DENTAL SYSTEMS, INC. 510(k) NO: K063856(TRADITIONAL)
ATTN: SUSAN D GOLDSTEIN-FALK PHONE NO : 949-429-5825
55 NORTHERN BLVD. SE DECISION MADE: 06-FEB-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS CS40B, CS40G,
ETHICON ENDO-SURGERY, LLC 510(k) NO: K062869(TRADITIONAL)
ATTN: DENNIS HAHN PHONE NO : 513-337-3134
4545 CREEK ROAD SE DECISION MADE: 26-FEB-07
CINCINNATI, OH 45242 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
ETHICON, INC. 510(k) NO: K063562(TRADITIONAL)
ATTN: PATRICE NAGODA PHONE NO : 908-218-2885
P.O. BOX 151 SE DECISION MADE: 26-FEB-07
ROUTE 22 WEST 510(k) SUMMARY AVAILABLE FROM FDA
SOMERVILLE, NJ 08876
DEVICE: EQUINOXE REVERSE SHOULDER SYSTEM
EXACTECH, INC. 510(k) NO: K063569(TRADITIONAL)
ATTN: AMNON TALMOR PHONE NO : 352-377-1140
2320 N.W. 66TH CT. SE DECISION MADE: 23-FEB-07
GAINESVILLE, FL 32653 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
EXCELSIOR MEDICAL CORP. 510(k) NO: K061497(TRADITIONAL)
ATTN: JOHN TALARICO PHONE NO : 732-642-6079
1933 HECK AVE SE DECISION MADE: 23-FEB-07
NEPTUNE, NJ 07753 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FINOMETER MODEL-2 WITH ACCESSORIES
FINAPRES MEDICAL SYSTEMS BV 510(k) NO: K063111(TRADITIONAL)
ATTN: GERAD J LANGEWOUTERS PHONE NO : 31 20 6090974
PAASHEUVELWEG 34A SE DECISION MADE: 01-FEB-07
AMSTERDAM ZO, NETHERLANDS NL-1105 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
FOCUS DIAGNOSTICS, INC. 510(k) NO: K062543(TRADITIONAL)
ATTN: MICHEAL J WAGNER,ESQ. PHONE NO : 714-220-1900
10703 PROGRESS WAY SE DECISION MADE: 01-FEB-07
CYPRESS, CA 90630-4737 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRISMA M10 PRE SET
GAMBRO RENAL PRODUCTS, INC. 510(k) NO: K063183(TRADITIONAL)
ATTN: JEFFREY R SHIDEMAN PHONE NO : 952-835-4018
7307 GLOUCHESTER DRIVE SE DECISION MADE: 15-FEB-07
EDINA, MN 55435 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: GC FUJI IX GP EXTRA
GC AMERICA, INC. 510(k) NO: K070319(SPECIAL)
ATTN: TERRY L JORITZ-LYONS PHONE NO : 708-926-3105
3737 WEST 127TH ST. SE DECISION MADE: 26-FEB-07
ALSIP, IL 60803 510(k) STATEMENT
DEVICE: CARDIODAY, VERSION 2.0
GETEMED MEDIZIN- UND INFORMATIONST510(k) NO: K070280(SPECIAL)
ATTN: ROMIL RAMBHIA PHONE NO : 516-482-9001
55 NORTHERN BLVD SE DECISION MADE: 23-FEB-07
SUITE 200 510(k) SUMMARY AVAILABLE FROM FDA
GREAT NECK, NY 11021
DEVICE: HEALADEX-P
HEALAGENICS, INC. 510(k) NO: K063517(TRADITIONAL)
ATTN: PAUL STRATI PHONE NO : 781-376-4114
800 WEST CUMMINGS PARK SE DECISION MADE: 16-FEB-07
SUITE 2900 510(k) SUMMARY AVAILABLE FROM FDA
WOBURN, MA 01801
DEVICE: HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIM
HILL LABORATORIES CO. 510(k) NO: K062256(TRADITIONAL)
ATTN: BRANDY ALTER PHONE NO : 610-644-2867
3 BACTON HILL RD. SE DECISION MADE: 26-FEB-07
FRAZER, PA 19355 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)
HL RUBBER INDUSTRIES SDN BHD 510(k) NO: K063522(TRADITIONAL)
ATTN: KENNY HOE PHONE NO : 606 481 1087
LOT 10, KAWASAN SE DECISION MADE: 08-FEB-07
PERINDUSTRIAN DIOH 510(k) STATEMENT
KUALA PILAH, NEGERI SEMBILAN, MALAYSIA 72000
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE
HONG DI PLASTIC PRODUCTS CO, LTD. 510(k) NO: K070187(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE. SE DECISION MADE: 13-FEB-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT
HOWMEDICA OSTEONICS CORP. 510(k) NO: K063857(TRADITIONAL)
ATTN: TIFFANI ROGERS PHONE NO : 201-831-5612
325 CORPORATE DR SE DECISION MADE: 26-FEB-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
HSINER CO., LTD. 510(k) NO: K063268(TRADITIONAL)
ATTN: TOM SHANKS PHONE NO : 951-506-2674
29201 VIA NORTE SE DECISION MADE: 23-FEB-07
TEMECULA, CA 92591 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FIBULA PLATE PROLOCK WITH ANGULAR STABILITY
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTE510(k) NO: K063672(TRADITIONAL)
ATTN: AL LIPPINCOTT PHONE NO : 952-492-5858
3150 E. 200TH ST. SE DECISION MADE: 02-FEB-07
PRIOR LAKE, MN 55372 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTRIC WHEELCHAIR, MODEL RUMBA S (HP4)
IMC-HEARTWAY, LLC 510(k) NO: K063203(ABBREVIATED)
ATTN: MICHAEL CHEN PHONE NO : 866-464-9779
6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 13-FEB-07
FORT MYERS, FL 33912 510(k) STATEMENT
DEVICE: ELECTRIC POWERED WHEELCHAIR, MODEL - RUMBA SR (4R)
IMC-HEARTWAY, LLC 510(k) NO: K063307(ABBREVIATED)
ATTN: MICHAEL CHEN PHONE NO : 866-464-9779
6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 27-FEB-07
FORT MYERS, FL 33912 510(k) STATEMENT
DEVICE: ELECTRIC POWERED LIFT WHEELCHAIR, MODEL VISION (P13)
IMC-HEARTWAY, LLC 510(k) NO: K063320(ABBREVIATED)
ATTN: MICHAEL CHEN PHONE NO : 866-464-9779
6140 MID METRO DRIVE, SUITE 6 SE DECISION MADE: 27-FEB-07
FORT MYERS, FL 33912 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CERTAIN PREVAIL DENTAL IMPLANT
IMPLANT INNOVATIONS, INC. 510(k) NO: K061629(SPECIAL)
ATTN: JIM BANIC PHONE NO : 561-776-6932
4555 RIVERSIDE DR. SE DECISION MADE: 23-FEB-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NANOTITE DENTAL IMPLANTS
IMPLANT INNOVATIONS, INC. 510(k) NO: K062432(TRADITIONAL)
ATTN: JACQUELYN A HUGHES PHONE NO : 561-776-6819
4555 RIVERSIDE DR. SE DECISION MADE: 22-FEB-07
PALM BEACH GARDENS, FL 33410 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HEMOSIL ANTITHROMBIN
INSTRUMENTATION LABORATORY CO. 510(k) NO: K070301(SPECIAL)
ATTN: CAROL MARBLE PHONE NO : 781-861-4467
113 HARTWELL AVE. SE DECISION MADE: 23-FEB-07
LEXINGTON, MA 02421 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: INTRALASE FUSION LASER
INTRALASE CORP. 510(k) NO: K063682(TRADITIONAL)
ATTN: JUDY GORDON PHONE NO : 949-715-0609
733 BOLSANA DRIVE SE DECISION MADE: 09-FEB-07
LAGUNA BEACH, CA 92651 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICE
IOMED, INC. 510(k) NO: K063465(TRADITIONAL)
ATTN: CURTIS JENSON PHONE NO : 801-975-1191
2441 SOUTH 3850 WEST, SUITE A SE DECISION MADE: 28-FEB-07
SALT LAKE CITY, UT 84120-9941 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
JIANGSU CUREGUARD GLOVE CO., LTD. 510(k) NO: K070075(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 527 4568102
ROOM 1606 BLDG. 1 JIANX. YUAN SE DECISION MADE: 09-FEB-07
NO. 209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA
HAIDIAN DISTRICT, BEIJING, CHINA 100083
DEVICE: POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED
JIANGSU CUREGUARD GLOVE CO., LTD. 510(k) NO: K070076(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 527 4568102
ROOM 1606 BLDG. 1 JIANX. YUAN SE DECISION MADE: 22-FEB-07
NO. 209 BEI SI HUAN ZHONG RD. 510(k) SUMMARY AVAILABLE FROM FDA
HAIDIAN DISTRICT, BEIJING, CHINA 100083
DEVICE: JUNIPER COOLING DEVICE XTRA
JUNIPER MEDICAL INC. 510(k) NO: K063715(TRADITIONAL)
ATTN: DON JOHNSON PHONE NO : 925-474-2509
7139 KOLL CENTER PKWY. SE DECISION MADE: 05-FEB-07
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
PLEASANTON, CA 94566
DEVICE: ALEUTIAN SPACER SYSTEM
K2M, INC. 510(k) NO: K063399(SPECIAL)
ATTN: RICH WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 23-FEB-07
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM
K2M, INC. 510(k) NO: K063544(SPECIAL)
ATTN: RICH WOODS PHONE NO : 703-777-3155
751 MILLER DR.,S.E., SUITE F1 SE DECISION MADE: 14-FEB-07
LEESBURG, VA 20175 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR
KARL STORZ ENDOSCOPY-AMERICA, INC.510(k) NO: K062464(TRADITIONAL)
ATTN: JAMES A LEE PHONE NO : 310-410-5597
600 CORPORATE POINTE SE DECISION MADE: 16-FEB-07
CULVER CITY, CA 90230-7600 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: KAVO EVEREST C-TEMP
KAVO AMERICA 510(k) NO: K063624(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 847-374-8854
PO BOX 7007 SE DECISION MADE: 08-FEB-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORE
KOSSAN LATEX INDUSTRIES(M)SDN BHD 510(k) NO: K062764(TRADITIONAL)
ATTN: LIM KWAN HWA PHONE NO : 603 339 27616
LOT 6129,JALAN HAJI ABDUL SE DECISION MADE: 27-FEB-07
MANAN, OFF JALAN MERU 510(k) SUMMARY AVAILABLE FROM FDA
KLANG, SELANGOR, MALAYSIA 41050
DEVICE: CLEARFIL MAJESTY FLOW
KURARAY AMERICA, INC. 510(k) NO: K063593(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
600 LEXINGTON AVE. SE DECISION MADE: 02-FEB-07
26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: CLEARFIL MAJESTY POSTERIOR
KURARAY AMERICA, INC. 510(k) NO: K063595(TRADITIONAL)
ATTN: KOJI NISHIDA PHONE NO : 212-986-2230
600 LEXINGTON AVE. SE DECISION MADE: 09-FEB-07
26TH FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
NEW YORK, NY 10022
DEVICE: LIBERTY NORMAL GLUCOSE CONTROL SOLUTION, MODEL 2120045/ HIGH GLU
LIBERTY HEALTHCARE GROUP, INC. 510(k) NO: K063855(TRADITIONAL)
ATTN: JOHN C GORMLEY PHONE NO : 830-372-1391
940 CROSSROADS BLVD. SE DECISION MADE: 01-FEB-07
SEGUIN, TX 78155 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LC THERAPY, MODEL LCT-1000
LITECURE, LLC 510(k) NO: K070400(TRADITIONAL)
ATTN: BRIAN PRYOR, PH.D. PHONE NO : 302-709-0408
930 OLD HARMONY ROAD SUITE A SE DECISION MADE: 28-FEB-07
NEWARK, DE 19713 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
MAQUET CRITICAL CARE AB 510(k) NO: K062793(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 908-947-2311
1140 ROUTE 22 EAST SE DECISION MADE: 07-FEB-07
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
BRIDGEWATER, NJ 08807
DEVICE: SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
MAQUET CRITICAL CARE AB 510(k) NO: K063404(TRADITIONAL)
ATTN: JAMIE YIEH PHONE NO : 908-947-2311
1140 ROUTE 22 EAST SE DECISION MADE: 15-FEB-07
SUITE 202 510(k) SUMMARY AVAILABLE FROM FDA
BRIDGEWATER, NJ 08807
DEVICE: MAXO2 CU
MAXTEC, INC. 510(k) NO: K063488(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. SE DECISION MADE: 22-FEB-07
# 102 510(k) SUMMARY AVAILABLE FROM FDA
BONITA SPRINGS, FL 34134
DEVICE: HEMOCATH II
MED-CONDUIT, INC. 510(k) NO: K062901(TRADITIONAL)
ATTN: GERALD G BOUSQUET PHONE NO : 978-302-5837
18 DERBY LANE SE DECISION MADE: 08-FEB-07
TYNGSBORO, MA 01879 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDELA DOMINANT 50 LIPO, MODEL 600-5706
MEDELA AG 510(k) NO: K063336(TRADITIONAL)
ATTN: WERNER FREI PHONE NO : 041 769 5151
LAETTICHSTRASSE 4B SE DECISION MADE: 26-FEB-07
BAAR, ZUG, SWITZERLAND CH-6341 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BALANCE REHABILITATION UNIT (BRU)
MEDICAA (URUGUAY) S.A. 510(k) NO: K070085(TRADITIONAL)
ATTN: IAN GORDON PHONE NO : 512-327-9997
1101 SOUTH CAPITAL TEXAS HWY. SE DECISION MADE: 26-FEB-07
SUITE F254 510(k) SUMMARY AVAILABLE FROM FDA
AUSTIN, TX 78746
DEVICE: SPYGLASS IRRIGATION SYSTEM
MEDICAL SCIENTIFIC, INC. 510(k) NO: K063700(TRADITIONAL)
ATTN: PAUL NARDELLA, JR. PHONE NO : 508-880-7313
125 JOHN HANCOCK RD. SE DECISION MADE: 08-FEB-07
TAUNTON, MA 02780 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EMBRYOASSIST
MEDICULT A/S 510(k) NO: K061309(TRADITIONAL)
ATTN: RONALD G LEONARDI PHONE NO : 858-586-0751
9915 CAM. CHIRIMOLLA SE DECISION MADE: 08-FEB-07
SAN DIEGO, CA 92131 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT D
MEDISYSTEMS CORP. 510(k) NO: K062953(TRADITIONAL)
ATTN: FREDRIC SWINDLER PHONE NO : 206-834-1226
701 PIKE STREET, SUITE 1600 SE DECISION MADE: 12-FEB-07
SEATTLE, WA 98101-3016 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CLAVIS
MEDTRONIC A/S 510(k) NO: K062478(ABBREVIATED)
ATTN: ANN-CHRISTINE PROVOOST PHONE NO : 45 44 579000
16-18 TONSBAKKEN SE DECISION MADE: 08-FEB-07
SKOVLUNDE, DENMARK DK-2740 510(k) STATEMENT
DEVICE: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
MEDTRONIC SOFAMOR DANEK, INC. 510(k) NO: K063100(TRADITIONAL)
ATTN: CHRISTINE SCIFERT PHONE NO : 901-396-3133
1800 PYRAMID PL. SE DECISION MADE: 23-FEB-07
MEMPHIS, TN 38132 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: IMMUNOCARD STAT! EHEC, MODEL 751630
MERIDIAN BIOSCIENCE, INC. 510(k) NO: K062546(TRADITIONAL)
ATTN: SUSAN ROLIH PHONE NO : 513-271-3700
3471 RIVER HILLS DR. SE DECISION MADE: 14-FEB-07
CINCINNATI, OH 45244 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MASTER CLASSIC 5K LOW SPEED HANDPIECE, 20K LOW SPEED HANDPIECE,
MTI PRECISION PRODUCTS 510(k) NO: K070001(SPECIAL)
ATTN: TOD BRENNER PHONE NO : 732-905-7440
175 OBERLIN AVE., NORTH SE DECISION MADE: 02-FEB-07
LAKEWOOD, NJ 08701 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
MULTISAFE SDN BHD 510(k) NO: K062527(TRADITIONAL)
ATTN: ABD HADI BIN HUSIN PHONE NO : 605 434 826972
LOT 764 SE DECISION MADE: 20-FEB-07
BIDOR INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
BIDOR, PERAK, MALAYSIA 35500
DEVICE: DBX STRIP
MUSCULOSKELETAL TRANSPLANT FOUNDAT510(k) NO: K062205(TRADITIONAL)
ATTN: NANCY BENNEWITZ PHONE NO : 732-661-0202
125 MAY ST, STE 300 SE DECISION MADE: 05-FEB-07
EDISON CORP CTR 510(k) SUMMARY AVAILABLE FROM FDA
EDISON, NJ 08837
DEVICE: SONIC-STIM
NAIMCO, INC. 510(k) NO: K063135(TRADITIONAL)
ATTN: JULIE CREASMAN PHONE NO : 423-648-7730
4120 SOUTH CREEK ROAD SE DECISION MADE: 05-FEB-07
CHATTANOOGA, TN 37406 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ORIGEN DBM WITH BIOACTIVE GLASS
NANOTHERAPEUTICS 510(k) NO: K062459(TRADITIONAL)
ATTN: PAULA WILKERSON PHONE NO : 352-262-8220
12337 NW 9TH LANE SE DECISION MADE: 26-FEB-07
NEWBERRY, FL 32669 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VASCUPUNCTURE PICC GUIDEWIRE
NEOMETRICS, INC. 510(k) NO: K070150(SPECIAL)
ATTN: GENE CHAMPEAU PHONE NO : 763-559-4440
14800 28TH AVE. N. SE DECISION MADE: 15-FEB-07
SUITE 150 510(k) SUMMARY AVAILABLE FROM FDA
PLYMOUTH, MN 55447
DEVICE: LISFRANC PLATE
NEWDEAL S.A. 510(k) NO: K063820(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 08-FEB-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO TTC PLATES
NEWDEAL S.A. 510(k) NO: K070160(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 08-FEB-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MODIFICATION TO LAPIDUS PLATE
NEWDEAL S.A. 510(k) NO: K070241(SPECIAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DRIVE SE DECISION MADE: 08-FEB-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BASAL DORSAL PLATES
NEWDEAL SAS 510(k) NO: K063831(TRADITIONAL)
ATTN: JUDITH E O'GRADY PHONE NO : 609-936-2311
311 ENTERPRISE DR. SE DECISION MADE: 07-FEB-07
PLAINSBORO, NJ 08536 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NIPRO BIOHOLE NEEDLE
NIPRO MEDICAL CORP. 510(k) NO: K063368(TRADITIONAL)
ATTN: JESSICA OSWALD PHONE NO : 305-599-7174
3150 NW 107 AVE.. SE DECISION MADE: 05-FEB-07
MIAMI, FL 33172 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NISSIN PEDIATRIC SERIES WHEELCHAIR
NISSIN MEDICAL INC. 510(k) NO: K063521(TRADITIONAL)
ATTN: TAKAHIRO HARUYAMA PHONE NO : 310-370-8484
3551 VOYAGER COURT, STE 102 SE DECISION MADE: 05-FEB-07
TORRANCE, CA 90503 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ADAPTER PS RP-NP, 34551, ADAPTER PS WP-RP,34552, ABUTMENT SCREW
NOBEL BIOCARE AB 510(k) NO: K063592(TRADITIONAL)
ATTN: HERBERT CRANE PHONE NO : 714-282-5074
15 BOHUSGATAN, SE DECISION MADE: 27-FEB-07
P.O. BOX 5190 510(k) SUMMARY AVAILABLE FROM FDA
GOTEBORG, SWEDEN S-402 26
DEVICE: NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
NOVABONE PRODUCTS, LLC 510(k) NO: K063549(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7669
ONE PROGRESS BLVD. SE DECISION MADE: 12-FEB-07
SUITE 33 510(k) SUMMARY AVAILABLE FROM FDA
ALACHUA, FL 32615
DEVICE: PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
NOVABONE PRODUCTS, LLC 510(k) NO: K063596(TRADITIONAL)
ATTN: DAVID M GAISSER PHONE NO : 386-462-7660
13709 PROGRESS BLVD., #33 SE DECISION MADE: 22-FEB-07
ALACHUA, FL 32615 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET
NOVAMED, LLC 510(k) NO: K063477(TRADITIONAL)
ATTN: PAUL DRYDEN PHONE NO : 239-498-2155
3460 POINTE CREEK CT. #102 SE DECISION MADE: 09-FEB-07
BONITA SPRINGS, FL 34134-2015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETER
OASIS MEDIKAL URUNLER KIMYA SANAYI510(k) NO: K062444(TRADITIONAL)
ATTN: CHARLES H KYPER PHONE NO : 919-598-8666
208 BARRINGTON OVERLOOK SE DECISION MADE: 22-FEB-07
DURHAM, NC 27703 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OK METER BLOOD GLUCOSE MONITORING SYSTEM
OK BIOTECH CO., LTD. 510(k) NO: K063026(TRADITIONAL)
ATTN: KE-MIN JEN PHONE NO : 886 3 5208829
NO. 58, FU-CHIUN ST. SE DECISION MADE: 09-FEB-07
HSIN-CHU CITY, CHINA (TAIWAN) 3006510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASO
OLYMPUS MEDICAL SYSTEMS CORPORATIO510(k) NO: K063683(TRADITIONAL)
ATTN: LAURA STORMS-TYLER PHONE NO : 484-896-5688
3500 CORPORATE PARKWAY SE DECISION MADE: 08-FEB-07
PO BOX 610 510(k) SUMMARY AVAILABLE FROM FDA
CENTER VALLEY, PA 18034-0610
DEVICE: OMNIGUIDE BEAM PATH CO2 MARK III WAVEGUIDE FIBER
OMNIGUIDE, INC. 510(k) NO: K070157(TRADITIONAL)
ATTN: DOUGLAS W WOODRUFF PHONE NO : 617-551-8404
ONE KENDALL SQUARE, BLDG 100 SE DECISION MADE: 01-FEB-07
3RD FLOOR 510(k) SUMMARY AVAILABLE FROM FDA
CAMBRIDGE, MA 02139 THIRD PARTY REVIEW
DEVICE: OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
OMRON HEALTHCARE, INC. 510(k) NO: K062263(TRADITIONAL)
ATTN: RANNDY KELLOGG PHONE NO : 847-247-5609
1200 LAKESIDE DRIVE SE DECISION MADE: 23-FEB-07
BANNOCKBURN, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND
ONSET MEDICAL CORPORATION 510(k) NO: K062852(TRADITIONAL)
ATTN: ALBERT REGO PHONE NO : 949-770-8710
27001 LA PAZ SUITE 312 SE DECISION MADE: 23-FEB-07
MISSION VIEJO, CA 92691 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DBX-H HEMOSTATIC DEMINERALIZED BONE MATRIX PUTTY
ORTHOCON, INC. 510(k) NO: K061131(TRADITIONAL)
ATTN: HOWARD SCHRAYER PHONE NO : 609-924-9510
167 STONE HILL ROAD SE DECISION MADE: 08-FEB-07
COLTS NECK, NJ 07722 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: EXCEL CONTRA ANGLE HANDPIECE
ORTHOSOURCE, INC. 510(k) NO: K061897(ABBREVIATED)
ATTN: LLOYD TAYLOR PHONE NO : 818-982-9445
13343 SHERMAN WAY SE DECISION MADE: 14-FEB-07
NORTH HOLLYWOOD, CA 91605 510(k) STATEMENT
DEVICE: PLEXUR P
OSTEOTECH, INC. 510(k) NO: K061982(TRADITIONAL)
ATTN: CHRISTOPHER W TALBOT PHONE NO : 732-542-2800
51 JAMES WAY SE DECISION MADE: 07-FEB-07
EATONTOWN, NJ 07724 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ELECTROPULSE - LOW BACK PAIN
PAIN RELIEF TECHNOLOGIES 510(k) NO: K062532(TRADITIONAL)
ATTN: KENDALL GORHAM PHONE NO : 480-231-0975
15048 SW CAPSTONE CT. SE DECISION MADE: 09-FEB-07
BEAVERTON, OR 97007 510(k) STATEMENT
DEVICE: SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT
PAJUNK GMBH MEDIZINTECHNOLOGIE 510(k) NO: K063697(TRADITIONAL)
ATTN: CHRISTIAN QUASS PHONE NO : 49 770 49291
KARL-HALL-STRASSE 1 SE DECISION MADE: 14-FEB-07
GEISINGEN, BADEN-WURTTEMBERG, GERM510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR LUX1540 HANDPIECE
PALOMAR MEDICAL PRODUCTS, INC. 510(k) NO: K061652(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414
82 CAMBRIDGE ST. SE DECISION MADE: 27-FEB-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PALOMAR LUX2940 HANDPIECE
PALOMAR MEDICAL TECHNOLOGIES, INC.510(k) NO: K063571(TRADITIONAL)
ATTN: SHARON TIMBERLAKE PHONE NO : 781-993-2414
82 CAMBRIDGE ST. SE DECISION MADE: 09-FEB-07
BURLINGTON, MA 01803 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PARI HYDRATE G
PARI INNOVATIVE MANUFACTURERS, INC510(k) NO: K070107(TRADITIONAL)
ATTN: MICHAEL JUDGE PHONE NO : 804-253-7274
2943 OAKLAKE BLVD. SE DECISION MADE: 23-FEB-07
MIDLOTHIAN, VA 23112 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (MMHG)
PHASEIN AB 510(k) NO: K063167(TRADITIONAL)
ATTN: DAVID WEISSBURG PHONE NO : 608-770-0223
4213 WINNEQUAH DR. SE DECISION MADE: 06-FEB-07
MADISON, WI 53716 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
PHILIPS MEDICAL SYSTEMS 510(k) NO: K070260(SPECIAL)
ATTN: DENISE HALEY PHONE NO : 978-659-4358
3000 MINUTEMAN RD. SE DECISION MADE: 23-FEB-07
M/S 0240 510(k) SUMMARY AVAILABLE FROM FDA
ANDOVER, MA 01810
DEVICE: MP5 INTELLIVUE PATIENT MONITOR
PHILIPS MEDIZINSYSTEME BOEBLINGEN 510(k) NO: K063725(TRADITIONAL)
ATTN: MARKUS STACHA PHONE NO : 49 703 14632840
HEWLETT-PACKARD STR.2 SE DECISION MADE: 08-FEB-07
BOEBLINGEN, GERMANY D 71034 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS
PHOTONIC OPTISCHE GERATE GMBH & CO510(k) NO: K070287(TRADITIONAL)
ATTN: DIETER FEGER PHONE NO : 43 148 656910
SEEBOCKGASSE 59 SE DECISION MADE: 12-FEB-07
VIENNA, AUSTRIA A-1160 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: CTLOGICS NAVIGATIONS SYSTEMS
PRAXIM MEDIVISION, SA 510(k) NO: K063408(TRADITIONAL)
ATTN: MADY BATAILH PHONE NO : 003 347 6549503
LE GRAND SABLON SE DECISION MADE: 28-FEB-07
4 AVENUE DE L'OBIOU 510(k) SUMMARY AVAILABLE FROM FDA
LA TRONCHE, FRANCE 38700
DEVICE: PRECISION OXYGEN MONITOR
PRECISION MEDICAL, INC. 510(k) NO: K063096(ABBREVIATED)
ATTN: JAMES PARKER PHONE NO : 610-262-6090
300 HELD DR. SE DECISION MADE: 27-FEB-07
NORTHAMPTON, PA 18067 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
PRIMUS CONSULTING 510(k) NO: K061252(TRADITIONAL)
ATTN: CAROLYN M PRIMUS PHONE NO : 941-753-9737
7046 OWL'S NEST TERRACE SE DECISION MADE: 12-FEB-07
BRADENTON, FL 34023 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
PRINCETON BIOMEDITECH CORP. 510(k) NO: K062565(TRADITIONAL)
ATTN: KYUNG-AH KIM PHONE NO : 732-274-1000
4242 U.S. RT. 1 SE DECISION MADE: 20-FEB-07
MONMOUTH JUNCTION, NJ 08852-1905 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
PURITAN BENNETT CORP. 510(k) NO: K063650(SPECIAL)
ATTN: PATRICK GARVEY PHONE NO : 925-463-4479
5391 PRIESTLY DR., SUITE 100 SE DECISION MADE: 15-FEB-07
CARLSBAD, CA 92008 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE LIBERTY FULL FACE MASK
RESMED LTD. 510(k) NO: K063011(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 02-FEB-07
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MIRAGE QUATTRO FULL FACE MASK
RESMED LTD. 510(k) NO: K063122(TRADITIONAL)
ATTN: DAVID D'CRUZ PHONE NO : 858-746-2238
14040 DANIELSON ST. SE DECISION MADE: 02-FEB-07
POWAY, CA 92064-6857 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SIDESTREAM PLUS
RESPIRONICS LTD. 510(k) NO: K062689(TRADITIONAL)
ATTN: LAUREN ZIEGLER PHONE NO : 973-571-2608
41 CANFIELD ROAD SE DECISION MADE: 16-FEB-07
CEDAR GROVE, NJ 07009 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: BIPAP SYNCHRONY
RESPIRONICS, INC. 510(k) NO: K063533(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 20-FEB-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: BIPAP AUTOSV
RESPIRONICS, INC. 510(k) NO: K063540(ABBREVIATED)
ATTN: ZITA A YURKO PHONE NO : 724-387-4120
1001 MURRY RIDGE LN. SE DECISION MADE: 22-FEB-07
MURRYSVILLE, PA 15668 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: MONITORING EAR THERMOMETER, MODEL BTM-D1A
RIO FLEXON TECHNOLOGY CO., LTD., 510(k) NO: K062445(TRADITIONAL)
ATTN: JEFF LIAO PHONE NO : 886 2 82218199
15F,868-2, JHONG JHENG RD., SE DECISION MADE: 16-FEB-07
JHONGHE CITY TAIPEI COUNTY, CHINA 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET
RITA MEDICAL SYSTEMS, INC. 510(k) NO: K062414(TRADITIONAL)
ATTN: DAVID SMITH PHONE NO : 706-846-3126
ONE HORIZON WAY SE DECISION MADE: 01-FEB-07
MANCHESTER, GA 31816 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: UNIBLATE ELECTROSURGICAL DEVICE
RITA MEDICAL SYSTEMS, INC. 510(k) NO: K070101(TRADITIONAL)
ATTN: KAM H LEUNG PHONE NO : 510-771-0440
46421 LANDING PARKWAY SE DECISION MADE: 14-FEB-07
FEMONT, CA 94538 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
ROCHE DIAGNOSTICS 510(k) NO: K063520(TRADITIONAL)
ATTN: KERWIN KAUFMAN PHONE NO : 317-521-7637
9115 HAGUE ROAD SE DECISION MADE: 16-FEB-07
INDIANAPOLIS, IN 46250 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CINCH BONE ANCHOR SYSTEM
SAPPHIRE MEDICAL, INC 510(k) NO: K062739(TRADITIONAL)
ATTN: JANICE M HOGAN PHONE NO : 267-675-4611
1835 MARKET STREET, 28TH FLOOR SE DECISION MADE: 13-FEB-07
PHILADELPHIA, PA 19103 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SCIENT'X SPINAL SYSTEM
SCIENT'X 510(k) NO: K062912(SPECIAL)
ATTN: J.D. WEBB PHONE NO : 512-388-0199
1001 OAKWOOD BLVD. SE DECISION MADE: 05-FEB-07
ROUND ROCK, TX 78681 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AEGIS
SENTINELLE MEDICAL, INC. 510(k) NO: K070244(TRADITIONAL)
ATTN: STEPHEN LEUNG PHONE NO : 416 482 3831
3080 YONGE STREET SE DECISION MADE: 09-FEB-07
SUITE 6020 510(k) SUMMARY AVAILABLE FROM FDA
TORONTO, ONTARIO, CANADA M4N 3N1 THIRD PARTY REVIEW
DEVICE: KODEA, MODELS XJ-2001AC; XJ-2002AS; XJ-2003A
SHANGHAI KODEA ECONOMIC AND TRADE 510(k) NO: K062893(ABBREVIATED)
ATTN: ZHAO J YU PHONE NO : 86 21 64041363
ROME. 902, NO.15, LANE 28, SE DECISION MADE: 05-FEB-07
QINGJIANG ROAD 510(k) STATEMENT
SHANGHAI, CHINA 200233
DEVICE: RUIKE, MODEL 3411
SHANGHAI RUIKE SPORTS GOODS CO., L510(k) NO: K062646(TRADITIONAL)
ATTN: JUNNATA CHANG PHONE NO : 886 4 22465396
14F-2, NO.1, LANE 25 SE DECISION MADE: 05-FEB-07
ZHUANGJING RD. 510(k) SUMMARY AVAILABLE FROM FDA
BANQIAO, TAIPEI COUNTY, CHINA (TAIWAN) 220
DEVICE: SHIJIAZHUANG JUNFEI PLASTICS PRODUCTS CO., LTD. POWDER FREE (WHI
SHIJIAZHUANG JUNFEI PLASTIC PRODUC510(k) NO: K063471(TRADITIONAL)
ATTN: KC CHEUNG PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 28-FEB-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE
SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070037(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7881
3973 SCHAEFER AVE SE DECISION MADE: 20-FEB-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT GLOVE
SHIJIAZHUANG LIANHE SHUNDA PLASTIC510(k) NO: K070046(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 07-FEB-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNGO DYNAMICS, VERSION 6.0
SIEMENS MEDICAL SOLUTIONS USA, INC510(k) NO: K070322(SPECIAL)
ATTN: SIEGLINDE NINA WEST PHONE NO : 734-205-2423
400 W. MORGAN ROAD SE DECISION MADE: 27-FEB-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
ANN ARBOR, MI 48108-9117 THIRD PARTY REVIEW
DEVICE: SBI LATERAL RADIO CAPITELLUM
SMALL BONE INNOVATIONS, INC. 510(k) NO: K070236(SPECIAL)
ATTN: ROBERT HOEHN PHONE NO : 212-583-0250
505 PARK AVENUE, 14TH FLOOR SE DECISION MADE: 21-FEB-07
NEWYORK, NY 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: CAPTION APPLICATOR
SMITH & NEPHEW, INC. 510(k) NO: K063535(TRADITIONAL)
ATTN: KIM P KELLY PHONE NO : 901-399-6566
1450 BROOKS RD. SE DECISION MADE: 26-FEB-07
MEMPHIS, TN 38116 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: 560 HIGH DEFINITION CAMERA SYSTEM
SMITH & NEPHEW, INC. 510(k) NO: K070266(SPECIAL)
ATTN: JANICE HASELTON PHONE NO : 978-749-1494
150 MINUTEMAN RD. SE DECISION MADE: 22-FEB-07
ANDOVER, MA 01810 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
SMITHS MEDICAL ASD, INC. 510(k) NO: K063755(TRADITIONAL)
ATTN: BRIAN FARIAS PHONE NO : 603-352-3812
10 BOWMAN DR. SE DECISION MADE: 27-FEB-07
KEENE, NH 03431 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DANA DIABECARE IIS
SOOIL DEVELOPMENT CO., LTD. 510(k) NO: K063126(SPECIAL)
ATTN: JEREMY KIM PHONE NO : 858-404-0659
5677 OBERLIN DRIVE, SUITE 101 SE DECISION MADE: 02-FEB-07
SAN DIEGO, CA 92121 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SOPRO 162 CAMERA
SOPRO 510(k) NO: K070102(TRADITIONAL)
ATTN: STEVE SALESKY PHONE NO : 800-289-6367
124 GAITHER DRIVE SE DECISION MADE: 20-FEB-07
SUITE 140 510(k) SUMMARY AVAILABLE FROM FDA
MT. LAUREL, NJ 08054
DEVICE: 15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24,
SPIRE BIOMEDICAL INC 510(k) NO: K063441(TRADITIONAL)
ATTN: SHEKHAR NIMKAR PHONE NO : 781-275-6001
ONE PATRIOTS PARK SE DECISION MADE: 12-FEB-07
BEDFORD, MA 01730 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM
SRA DEVELOPMENTS, LTD. 510(k) NO: K063531(TRADITIONAL)
ATTN: MICHAEL J.R. YOUNG PHONE NO : 44 136 4652426
BREMRIDGE HOUSE SE DECISION MADE: 22-FEB-07
ASHBURTON, DEVON, UNITED KINGDOM T510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: HARMONIE SYSTEM
STELLATE SYSTEMS 510(k) NO: K061911(ABBREVIATED)
ATTN: ELIANE SCHAEFER PHONE NO : 514 486 1306
376 VICTORIA AVE, SUITE 200 SE DECISION MADE: 23-FEB-07
WESTMOUNT, QUEBEC, CANADA H3Z 1C3 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: RETIC-CHEX LINEARITY FOR BC
STRECK 510(k) NO: K070199(TRADITIONAL)
ATTN: KERRIE OETTER PHONE NO : 402-537-5215
7002 SOUTH 109TH ST. SE DECISION MADE: 23-FEB-07
OMAHA, NE 68128 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER AUTO IRRIGATION SYSTEM
STRYKER 510(k) NO: K061108(TRADITIONAL)
ATTN: VALERIE FRANCK PHONE NO : 269-323-7700
4100 EAST MILHAM AVENUE SE DECISION MADE: 02-FEB-07
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: STRYKER T4 HYTREL TOGA
STRYKER INSTRUMENTS, INSTRUMENTS D510(k) NO: K070078(SPECIAL)
ATTN: PAULETTE D JOHNSON PHONE NO : 269-323-7700
4100 EAST MILHAM AVE. SE DECISION MADE: 02-FEB-07
KALAMAZOO, MI 49001 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: PCA ALUMINA FEMORAL HEADS
STRYKER ORTHOPAEDICS 510(k) NO: K063816(TRADITIONAL)
ATTN: PATRICIA SETTI-LAPERCH PHONE NO : 201-831-5938
325 CORPORATE DRIVE SE DECISION MADE: 02-FEB-07
MAHWAH, NJ 07430 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM
SUNI MEDICAL IMAGING, INC. 510(k) NO: K070219(TRADITIONAL)
ATTN: DAVID STARK PHONE NO : 415-888-3700
38 MILLER AVE, PMB 170 SE DECISION MADE: 07-FEB-07
MILL VALLEY, CA 94941 510(k) SUMMARY AVAILABLE FROM FDA
THIRD PARTY REVIEW
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVE
SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070030(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 16-FEB-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW
SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070042(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE SE DECISION MADE: 23-FEB-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE
SUPER SAFE PLASTIC PRODUCTS CO., L510(k) NO: K070043(TRADITIONAL)
ATTN: KATHY LIU PHONE NO : 909-591-7888
3973 SCHAEFER AVE. SE DECISION MADE: 08-FEB-07
CHINO, CA 91710 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORSURE DISPOSABLE SYRINGE WITH NEEDLE, MODEL 1CC, 3C, 5CC, 10CC
SURGIMED, INC. 510(k) NO: K062753(ABBREVIATED)
ATTN: FERNANDO LAVOI PHONE NO : 305-594-1121
1303 NW 78 AVE SE DECISION MADE: 08-FEB-07
MIAMI, FL 33126 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SURGINETICS ADVANTAGEBLADE
SURGINETICS 510(k) NO: K062350(TRADITIONAL)
ATTN: MANETA D LOLLAR PHONE NO : 303-339-8206
4900 PEARL EAST CIRCLE SE DECISION MADE: 26-FEB-07
SUITE 100 510(k) SUMMARY AVAILABLE FROM FDA
BOULDER, CO 80301
DEVICE: SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, S
SUTURTEK INCORPORATED 510(k) NO: K063603(ABBREVIATED)
ATTN: ART RANKIS PHONE NO : 508-847-5961
6 BROOKSIDE CIRCLE SE DECISION MADE: 07-FEB-07
ACTON, MA 01720 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
SYNTHES (USA) 510(k) NO: K062789(TRADITIONAL)
ATTN: JEFFREY DOW PHONE NO : 484-356-9720
1230 WILSON DRIVE SE DECISION MADE: 27-FEB-07
WEST CHESTER, PA 19380 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERS
TECHNOMED EUROPE 510(k) NO: K062437(TRADITIONAL)
ATTN: RENE RONCKEN PHONE NO : 314 340 86868
AMERIKALAAN 71 SE DECISION MADE: 16-FEB-07
MAASTRICHT AIRPORT, NETHERLANDS 61510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: FORCE FIBER POLYETHYLENE NONABSORBABLE SUTURE
TELEFLEX MEDICAL 510(k) NO: K063778(ABBREVIATED)
ATTN: LORI HAYS PHONE NO : 847-572-8027
2345 WAUKEGAN ROAD SE DECISION MADE: 09-FEB-07
SUITE 120 510(k) SUMMARY AVAILABLE FROM FDA
BANNOCKBURN, IL 60015
DEVICE: FINECUBE DENTAL CT
THE YOSHIDA DENTAL MFG. CO., LTD. 510(k) NO: K063622(TRADITIONAL)
ATTN: DANIEL KAMM PHONE NO : 874-374-8854
P.O. BOX 7007 SE DECISION MADE: 08-FEB-07
DEERFIELD, IL 60015 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: THERMOMED 1.8
THERMOSURGERY TECHNOLOGIES, INC. 510(k) NO: K063748(TRADITIONAL)
ATTN: GENE ZISCHKE PHONE NO : 602-264-7300
2901 W. INDIAN SCHOOL RD. SE DECISION MADE: 01-FEB-07
PHOENIX, AZ 85017-4162 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1
TISSUELINK MEDICAL, INC. 510(k) NO: K063639(TRADITIONAL)
ATTN: VICKI ANASTASI PHONE NO : 603-742-1515
ONE WASHINGTON CENTER SE DECISION MADE: 22-FEB-07
SUITE #400 510(k) SUMMARY AVAILABLE FROM FDA
DOVER, NH 03820
DEVICE: TOP NEUROPOLE NEEDLES, MODELS ST, X, RC, XE AND TL
TOP CORP. 510(k) NO: K062946(TRADITIONAL)
ATTN: CATHRYN N CAMBRIA PHONE NO : 770-396-5909
5536 TROWBRIDGE DRIVE SE DECISION MADE: 15-FEB-07
DUNWOODY, GA 30338 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TUTTNAUER PREVACUUM STEAM HEATED AUTOCLAVE, MODELS 6990 SP-1A, 6
TUTTNAUER CO. LTD. 510(k) NO: K063711(TRADITIONAL)
ATTN: MARK YACURA PHONE NO : 202-452-7949
1776 K ST. N.W. SE DECISION MADE: 02-FEB-07
SUITE 300 510(k) SUMMARY AVAILABLE FROM FDA
WASHINGTON, DC 20006-2365
DEVICE: BODIHEALTH SYSTEM
USA LASER THERAPEUTICS, INC. 510(k) NO: K052836(TRADITIONAL)
ATTN: M. JOYCE HEINRICH PHONE NO : 713-734-4433
12101 CULLEN BLVD., #A SE DECISION MADE: 13-FEB-07
HOUSTON, TX 77047 510(k) STATEMENT
DEVICE: TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYS
VARIAN MEDICAL SYSTEMS, INC. 510(k) NO: K070094(SPECIAL)
ATTN: VY TRAN PHONE NO : 650-842-5731
3100 HANSEN WAY SE DECISION MADE: 09-FEB-07
MS E-110 510(k) SUMMARY AVAILABLE FROM FDA
PALO ALTO, CA 94304
DEVICE: THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT
VASCULAR SOLUTIONS, INC. 510(k) NO: K063860(TRADITIONAL)
ATTN: JAMES CHAPMAN PHONE NO : 763-656-4380
6464 SYCAMORE COURT NORTH SE DECISION MADE: 13-FEB-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: D-STAT HANDLE, MODEL 8500-053
VASCULAR SOLUTIONS, INC. 510(k) NO: K063871(TRADITIONAL)
ATTN: ALYSSA MALINSKI PHONE NO : 763-656-4300
6464 SYCAMORE COURT NORTH SE DECISION MADE: 28-FEB-07
MINNEAPOLIS, MN 55369 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: TEMPORARY LIMB SALVAGE SHUNT
VASCUTEK LTD. 510(k) NO: K070323(TRADITIONAL)
ATTN: KAREN KELSO PHONE NO : 44 141 8125555
NEWMAINS AVE. SE DECISION MADE: 15-FEB-07
INCHINNAN INDUSTRIAL ESTATE 510(k) SUMMARY AVAILABLE FROM FDA
RENFREWSHIRE,GLASGOW,SCOTLAND, UNITED KINGDOM PA4 9RR
DEVICE: WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
WAKO CHEMICALS, USA, INC. 510(k) NO: K061775(TRADITIONAL)
ATTN: LORI CREASY PHONE NO : 804-714-1932
1600 BELLWOOD ROAD SE DECISION MADE: 23-FEB-07
RICHMOND, VA 23237 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: LORENZ ORTHODONTIC ANCHORAGE SYSTEM
WALTER LORENZ SURGICAL, INC. 510(k) NO: K063386(TRADITIONAL)
ATTN: KIM REED PHONE NO : 904-741-4400
1520 TRADEPORT DR. SE DECISION MADE: 09-FEB-07
JACKSONVILLE, FL 32218 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2407
WELL-LIFE HEALTHCARE LIMITED 510(k) NO: K063660(SPECIAL)
ATTN: JENNY HSIEH PHONE NO : 886 2 29282112
68 MODY ROAD SE DECISION MADE: 07-FEB-07
TSIMSHATSUIM 510(k) SUMMARY AVAILABLE FROM FDA
KOWLOON, HONG KONG
DEVICE: CO2 EASY
WESTMED, INC. 510(k) NO: K070128(TRADITIONAL)
ATTN: DALE BICKLEY PHONE NO : 520-294-7987
5580 S. NOGALES HIGHWAY SE DECISION MADE: 15-FEB-07
TUCSON, AZ 85706 510(k) STATEMENT
THIRD PARTY REVIEW
DEVICE: XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VAS
WITT BIOMEDICAL CORP 510(k) NO: K063840(TRADITIONAL)
ATTN: JAMES LUKER PHONE NO : 321-253-5693
305 NORTH DR. SE DECISION MADE: 06-FEB-07
MELBOURNE, FL 32934 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
WUXI SHENZHOU PLASTIC PRODUCTS CO.510(k) NO: K070145(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
209 BEI SI HUAN ZHONG RD, BD 1 SE DECISION MADE: 28-FEB-07
ROOM 1606, JIANXIANG YUAN 510(k) SUMMARY AVAILABLE FROM FDA
HAIDIAN DISTRICT, BEIJING, CHINA 100083
DEVICE: POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
WUXI SHENZHOU PLASTIC PRODUCTS CO.510(k) NO: K070149(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
209 BEI SI HUAN ZHONG RD, BD 1 SE DECISION MADE: 23-FEB-07
ROOM 1606, JIANXIANG YUAN 510(k) SUMMARY AVAILABLE FROM FDA
HAIDIAN DISTRICT, BEIJING, CHINA 100083
DEVICE: POWDERED VINYL PATIENT EXAMINATION GLOVES
ZIBO HENGDE PLASTIC & RUBBER PRODU510(k) NO: K070008(TRADITIONAL)
ATTN: CHU XIAOAN PHONE NO : 86 10 82387441
NO. 209 BEI SI HUAN ZHONG ROAD SE DECISION MADE: 08-FEB-07
BEIJING, CHINA 10083 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11,
ZIMMER DENTAL INC. 510(k) NO: K063523(TRADITIONAL)
ATTN: ERIN MCVEY PHONE NO : 760-929-4300
1900 ASTON AVE. SE DECISION MADE: 16-FEB-07
CARLSBAD, CA 92008-7308 510(k) SUMMARY AVAILABLE FROM FDA
DEVICE: ZOLL M SERIES WITH REAL CPR HELP
ZOLL MEDICAL CORPORATION 510(k) NO: K062537(TRADITIONAL)
ATTN: SEAN REYNOLDS PHONE NO : 978-421-9386
269 MILL ROAD SE DECISION MADE: 28-FEB-07
CHELMSFORD, MA 01824-4105 510(k) SUMMARY AVAILABLE FROM FDA
TOTAL 510(k)s THIS PERIOD 215
TOTAL WITH SUMMARIES 202
TOTAL WITH STATEMENTS 13
Updated March 5, 2007
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