FDA 510(k) Applications Submitted by HOWARD HOLSTEIN

FDA 510(k) Number Submission Date Device Name Applicant
K030554 02/21/2003 CALLOS SKELETAL KINETICS, LLC
K110500 02/22/2011 STAT-MAT MINOR MACPHERSON MEDICAL, INC.
K040714 03/18/2004 HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT INNOVA CORP.
K013021 09/07/2001 LIGHTLANCE LASER SKIN PERFORATOR INNOTECH USA, INC.
K052951 10/20/2005 ENDOPORE ANATOMIC ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP.
K043190 11/17/2004 SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP.
K053242 11/18/2005 PITT-EASY DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP.
K053403 12/06/2005 LUCAS JOLIFE AB
K053554 12/20/2005 COMPUFLO MILESTONE SCIENTIFIC, INC.
K024261 12/23/2002 DENTAL PROTECTOR DENTAL CONCEPTS LLC.
K072420 08/28/2007 MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE OCEANIC MEDICAL PRODUCTS, INC.
K072147 08/03/2007 DEN TEK COMFORT FIT NIGHTGUARD DEN TEK ORAL CARE, INC.
K984540 12/21/1998 KERAVISION VACUUM RING SYSTEM KERAVISION, INC.
K060193 01/25/2006 MAGELLAN-2200 MODEL -2 ANESTHESIA MACHINE, MODEL 2 OCEANIC MEDICAL PRODUCTS, INC.
K960433 01/31/1996 VST-10, VST-10/2 VCARE INTL., INC.
K960477 02/01/1996 VENTILATION TUBES SMITH & NEPHEW, INC.
K000406 02/07/2000 RHINOSCAN MODEL SRE2000/ SRE2100 WITH ACOUSTIC RHINOMETRY MODULE RHINOMETRICS A/S
K020447 02/11/2002 MITYVAC MERLIN, MODEL 10027 PRISM ENTERPRISES, INC.
K060424 02/17/2006 PANORAMIC, MODEL 200MA OPTOS PLC
K090422 02/18/2009 LUCAS 2 JOLIFE AB
K040520 02/27/2004 SLIP UROLOGY INTRODUCER SHEATH PERCUTANEOUS SYSTEMS, INC.
K040519 02/27/2004 SLIP UROLOGY CATHETER PERCUTANEOUS SYSTEMS, INC.
K100644 03/05/2010 OPTOS LIMITED PANORAMIC 200CAF OPTOS PLC
K010716 03/09/2001 VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB VAL MED CORP.
K990871 03/16/1999 PILLOWPOSITIVE CERVICAL PILLOW LIFESLEEP SYSTEMS, INC.
K010950 03/29/2001 CYPRESS SYSTEM ACUSON CORP.
K971196 03/31/1997 ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA CORP.
K021056 04/01/2002 PERMACOL TISSUE SCIENCE LABORATORIES, PLC
K991272 04/13/1999 CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E GALIL MEDICAL LTD.
K021202 04/16/2002 ULTRAQUIET SOUND TECHNIQUE SYSTEM, LLC
K971592 05/01/1997 XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM THE SILCRAFT CORP.
K971593 05/01/1997 SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT THE SILCRAFT CORP.
K971685 05/07/1997 IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM TOMEY CORPORATION USA
K952273 05/15/1995 HANDMASTER NMS1 NEUROMUSCLAR ELECTRICAL STIMULATION SYSTEMS, LTD.
K031550 05/16/2003 REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE VIVOMETRICS, INC.
K942389 05/18/1994 TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES HOGAN & HARTSON
K011532 05/18/2001 MITYVAC PRISM ENTERPRISES, INC.
K061445 05/24/2006 SURGIMESH WN ASPIDE MEDICAL
DEN020001 05/28/2002 BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL
K091660 06/09/2009 CUSTOM COMFORT NIGHTGUARD VERSION 2 DENTEK ORAL CARE, INC.
K111628 06/10/2011 P200T OPTOS PLC
K081669 06/13/2008 IMPROVED COMFORT-FIT NIGHTGUARD DENTEK ORAL CARE, INC.
K962369 06/19/1996 TALKING DIGITAL THERMOMETER ULTMOST INDUSTRIAL CORP.
K071759 06/28/2007 LTC VAD SYSTEM, MODELS #VAD.400 (ELECTROSURGICAL GENERATOR); PCS-900 AND PCC-900 (HAND PIECE INSTRUMENTS) LIVE TISSUE CONNECT, INC.
K002046 07/05/2000 MODIFICATION TO AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 VSM TECHNOLOGY, INC.
K032140 07/11/2003 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP.
K002157 07/17/2000 RANGER II M6, MODEL IN-888WNL INVACARE CORP.
K982532 07/20/1998 PARIETEX COGENT
K092233 07/23/2009 SURGIMESH XD ASPIDE MEDICAL
K042001 07/26/2004 PANORAMIC 200A OPTOS PLC
K953598 08/01/1995 SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS SERONO DIAGNOSTICS, INC.
K972857 08/01/1997 SERVOTRONIC EC100 SYSTEM MEDICON, E.G.
K092375 08/05/2009 MODIFICATION TO SI JOINT FUSION SYSTEM SI-BONE, INC.
K992631 08/06/1999 ACUNAV DIAGNOSTIC ULTRASOUND CATHETER ACUSON CORP.
K022643 08/08/2002 BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 SWEMED LAB INTERNATIONAL AB
K992655 08/09/1999 FERTILOSCOPY KIT FH 1.29/FTO 1.40 SOPRANE S.A.
K002479 08/11/2000 BIOMESH P1 AND BIOMESH PLUG AND PATCH COUSIN BIOTECH S.A.R.L
K082351 08/15/2008 NEPTUNE HYPERBARIC VENTILATOR LEVEL-5, INC.
K062401 08/16/2006 MODIFICATION TO LUCAS JOLIFE AB
K973162 08/22/1997 DUAL RADIATION TARGETING SYSTEM DRTS DRAPE HOGAN & HARTSON
K102492 08/31/2010 P200MAAF OPTOS PLC
K993010 09/07/1999 BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER ENVIRONMENTAL TECTONICS CORP.
K013040 09/10/2001 LIGHT SABER INTRODUCER NEEDLE MINRAD, INC.
K954547 09/29/1995 CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER CITIZEN WATCH CO., LTD.
K052735 09/30/2005 ALLOCRAFT DBM LIFECELL CORP.
K033251 10/07/2003 THE FRIENDLYLIGHT ND: YAG LASERS INNOTECH USA, INC.
K954722 10/13/1995 MICRO-DISPENSER 7000 & MICRODISPENSER 8000 NOUVAG AG
K072974 10/22/2007 SURGIMESH XB ASPIDE MEDICAL
K053112 11/04/2005 BIOSIGN OXFORD BIOSIGNALS LIMITED
K013625 11/05/2001 PERMACOL TISSUE SCIENCE LABORATORIES, PLC
K983999 11/09/1998 PANORAMIC200 OPTHALMOSCOPE OPTOS PLC
K073213 11/14/2007 THERABOND ANTIMICROBIAL BARRIER SYSTEMS CHOICE THERAPEUTICS
K984117 11/17/1998 INNOVA TELESCOPIC DISTRACTOR INNOVA CORP.
K083400 11/17/2008 CUSTOM COMFORT NIGHTGUARD DENTEK ORAL CARE, INC.
K984313 12/02/1998 HTU3 HYOX SYSTEMS LTD.
K113696 12/16/2011 OPTOS ADVANCE OPTOS PLC
K053580 12/22/2005 DOCTOR'S NIGHTGUARD DENTAL CONCEPTS LLC.
K994423 12/29/1999 AUTOMATED NON-INVASIVE BLOOD PRESSURE MONITOR, MODEL BPM-100 VSM MEDTECH LTD.
K043604 12/29/2004 LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE VIVOMETRICS, INC.
K973424 09/10/1997 ENFRESH TONGUE BRUSH ENFRESH PRODUCTS LLC.
K980212 01/21/1998 MITYVAC PRISM TECHNOLOGIES, INC.
K970256 01/23/1997 INTRAORAL MANDIBULAR DISTRACTION DEVICE MEDICON, E.G.
K010754 03/13/2001 NURSE'S ASSISTANT O.R. CONTROL SYSTEM VAL MED CORP.
K962087 05/28/1996 SERVOTRONIC EC100 SYSTEM MEDICON, INC.


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