FDA 510(k) Applications Submitted by PAMELA PAPINEAU, RAC

FDA 510(k) Number Submission Date Device Name Applicant
K080042 01/08/2008 SPIRUS MEDICAL SURGICAL INSTRUMENT SPIRUS MEDICAL, INC.
K080050 01/08/2008 SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE SPIRUS MEDICAL, INC.
K060075 01/10/2006 FIBER-METAL POST FOREMOST DENTAL LLC.
K100062 01/11/2010 INFILTRATION KIT DMG USA, INC.
K010219 01/24/2001 CHALLENGER DIRECT COMPOSITE INTERNATIONAL DENTAL RESEARCH
K090193 01/27/2009 CONDUCTOR CORONARY GUIDEWIRE CONCERT MEDICAL, LLC
K040215 01/30/2004 VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM VISION-SCIENCES, INC.
K060235 01/30/2006 ENDO-EASE ENDOSCOPIC OVERTUBE SPIRUS MEDICAL, INC.
K990354 02/05/1999 ENDOSHEATH VISION-SCIENCES, INC.
K950809 02/22/1995 VISION-SCIENCES DISPOSABLE ENDOSHEATH FOR FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES VISION-SCIENCES, INC.
K080480 02/22/2008 NANOCOMPOSITE RESTORATIVE KIT DMG USA, INC.
K080479 02/22/2008 DENTAL CERAMIC DMG USA, INC.
K980804 03/02/1998 SABRE BT BLUNT0TIP SURGICAL TROCAR ENDOSCOPIC CONCEPTS, INC.
K060552 03/02/2006 BC100 BODY COMPOSITION ANALYSIS SYSTEM ATHLETIC IQ, INC.
K080645 03/06/2008 STD MED PRIMO PORT POLY STD MED, INC.
K110759 03/18/2011 TEMPOCEM DMG USA, INC.
K000878 03/20/2000 HONIGUM DMG USA, INC.
K000951 03/23/2000 LUXAFORM DMG USA, INC.
K991098 04/01/1999 DIFOTI SYSTEM ELECTRO-OPTICAL SCIENCES, INC.
K080905 04/01/2008 QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI QUANTUM MEDICAL IMAGING, LLC.
K070911 04/02/2007 STD MED PRIMO PORT STD MED, INC.
K991172 04/07/1999 IONOSIT BOND DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
K031128 04/09/2003 B-SMART, MODEL B-01 MACOSTA MEDICAL USA, LLC
K040984 04/15/2004 VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE VISION-SCIENCES, INC.
K050972 04/18/2005 VISION-SCIENCES ENT-3000 SCOPE VISION-SCIENCES, INC.
K011211 04/19/2001 FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW DMG USA, INC.
K031292 04/23/2003 MODIFICATION TO FOSSA URETERAL STONE SWEEPER FOSSA MEDICAL, INC.
K071127 04/23/2007 FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM VISION-SCIENCES, INC.
K021344 04/29/2002 B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM VISION-SCIENCES, INC.
K041271 05/12/2004 STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM STERNGOLD
K021602 05/15/2002 FOSSA URETERAL STONE SWEEPER FOSSA INDUSTRIES, INC.
K081493 05/28/2008 INFILTRATION KIT DMG USA, INC.
K001723 06/06/2000 COOL-TEC ELECTRODES SEEDLING ENTERPRISES. LLC.
K051503 06/07/2005 UGYTEX SUAL KNIT MESH SOFRADIM PRODUCTION
K071579 06/08/2007 PEF TUBE N.M. BEALE CO. INC.
K031786 06/10/2003 TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM VISION-SCIENCES, INC.
K031790 06/10/2003 SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING VISION-SCIENCES, INC.
K101710 06/17/2010 LUXATEMP ULTRA /STAR DMG USA, INC.
K002086 07/10/2000 PRIMAFLOW DMG USA, INC.
K071903 07/10/2007 ENDOSHEATH SYSTEMS FOR USE WITH VISION-SCIENCES TNE SCOPE VISION-SCIENCES, INC.
K041960 07/21/2004 COMPOSITE/COMPOMER REPAIR KIT DMG USA, INC.
K012307 07/23/2001 LUXACORE/LUXACORE DUAL DMG USA, INC.
K012316 07/23/2001 PERMACEM / PERMACEM DUAL DMG USA, INC.
K982626 07/28/1998 URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 MEDWORKS CORP.
K982628 07/28/1998 MEDWORKS INSEMINATION CATHETER MEDWORKS CORP.
K982630 07/28/1998 MEDWORKS VISUALIZATION INSEMINATION CATHETER MEDWORKS CORP.
K072073 07/30/2007 VISION-SCIENCES ENT-5000 AND ENT-5100 VIDEO ENT SCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR VISION-SCIENCES, INC.
K072088 07/30/2007 FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMS VISION-SCIENCES, INC.
K052084 08/02/2005 ENDO-EASE ENDOSCOPIC OVERTUBE SPIRUS MEDICAL, INC.
K982692 08/03/1998 STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC STERNGOLD/IMPLAMED
K072180 08/06/2007 VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM VISION-SCIENCES, INC.
K982895 08/17/1998 STERNOMEGA COMPOMER CEMENT STERNGOLD/IMPLAMED
K963344 08/26/1996 DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE VISION-SCIENCES, INC.
K992879 08/26/1999 ECUSIT COMPOSITE REPAIR DMG HAMBURG
K102603 09/10/2010 SA FLOWABLE ADHESIVE DMG USA, INC.
K002841 09/12/2000 COOL-TEC ELECTRODES SEEDLING ENTERPRISES. LLC.
K062805 09/19/2006 MODIFICATION TO ENDO-EASE SPIRUS MEDICAL, INC.
K013179 09/24/2001 LUXAGLAZE DMG USA, INC.
K013236 09/28/2001 LUXABITE DMG USA, INC.
K013237 09/28/2001 STATUSBLUE DMG USA, INC.
K973734 09/30/1997 STERILE WATER FOR DEVICE IRRIGATION/ STERILE SALINE FOR DEVICE IRRIGATION WELCON, INC.
K052800 10/03/2005 PROVISIONAL INLAY/ONLAY KIT DMG USA, INC.
K033227 10/06/2003 LUXAFORM PLUS DMG USA, INC.
K964100 10/11/1996 VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100 VISION-SCIENCES, INC.
K093338 10/23/2009 SELF ADHESIVE COMPOSITE LUTING CEMENT DMG USA, INC.
K023580 10/24/2002 STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM STERNGOLD
K093329 10/26/2009 SCOPE INTRODUCER MODEL 7400 N.M. BEALE CO. INC.
K013571 10/29/2001 MAGICFIL DMG USA, INC.
K964326 10/30/1996 VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEM VISION-SCIENCES, INC.
K023649 10/30/2002 VITIQUE SYSTEM DMG USA, INC.
K003402 11/01/2000 WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION WELCON, INC.
K964397 11/04/1996 THERAPIK THE JENEX CORPORATION
K013674 11/07/2001 LUXATEMP/LUXATEMP SOLAR/INSTATEMP DMG USA, INC.
K093477 11/09/2009 SHIELD KYPHOPLASTY SYSTEM SOTEIRA, INC.
K063444 11/15/2006 TOTAL ETCH BONDING AGENT DMG USA, INC.
K093587 11/19/2009 DENTAL MERCURY DMG USA, INC.
K093584 11/19/2009 EZ-MISTER N.M. BEALE CO. INC.
K053412 12/07/2005 FLEXISCOPE, MODELS 50MH AND 50 MHC SCHOELLY IMAGING, INC.
K024095 12/12/2002 MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM VISION-SCIENCES, INC.
K024165 12/17/2002 DUAL-LUMEN CATHETER BISTECH, INC.
K053560 12/21/2005 MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE VISION-SCIENCES, INC.
K130580 03/05/2013 RETRACTION PASTE DMG USA, INC.
K141400 05/28/2014 DCCERAM SYSTEM CERAMAY GMBH & CO.KG
K132009 07/01/2013 CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM SCHOELLY FIBEROPTIC, GMBH
K082504 08/29/2008 APOLLO ANTERIOR CERVICAL PLATE SYSTEM APOLLO SPINE, INC.
K133682 12/02/2013 SCHOELLY ARTHROSCOPE SCHOLLY FIBEROPTIC GMBH
K961591 04/24/1996 DISPOSABLE ENDOSHEATH FOR E-F100 FLEXIBLE NASOPHARYNGOSCOPE VISION-SCIENCES, INC.
K963795 09/23/1996 VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE ENDOSHEATH VISION-SCIENCES, INC.


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