FDA 510(k) Applications Submitted by Harry Harry

FDA 510(k) Number Submission Date Device Name Applicant
K130135 01/18/2013 DANA REUSABLE BI TEST PACK DANA PRODUCTS, INC.
K110253 01/28/2011 REUSABLE TEST PACK FOR DANA EMULATING INDICATORS DANA PRODUCTS, INC.
K120592 02/28/2012 DANA REUSABLE BOWIE TEST PACK FOR DANA BOWIE DICK INDICATORS DANA PRODUCTS, INC.
K100891 03/31/2010 DANA EMULATING INDICATOR DANA PRODUCTS, INC.
K012195 07/13/2001 STEAM STERILIZATION INTERGRATOR DANA PRODUCTS, INC.
K102761 09/23/2010 DANA REUSABLE TEST PACK FOR STEAM STERILIZATION DANA PRODUCTS, INC.
K092944 09/24/2009 DANA REUSABLE TEST PACK FOR STEAM STERILIZATION DANA PRODUCTS, INC.
K133267 10/24/2013 DANA REUSABLE TEST PACK DANA PRODUCTS, INC.
K103321 11/12/2010 DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES DANA PRODUCTS, INC.
K020400 02/06/2002 DIGITIMER D185 MULTIPULSE CORTICAL STIMULATOR MEPS, LLC.
K121007 04/03/2012 NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE T, NEO DELTA SELF SAFE 1, NEO DELTA SELF SAFE 1 DELTA MED SRL
K060058 01/09/2006 STELLAR 404T LARSEN & TOUBRO LIMITED
K042560 09/21/2004 STELLAR 404 MONITORING SYSTEM LARSEN & TOUBRO LIMITED
K212717 08/27/2021 Paneffort AAMI Level 3 Isolation Gown Paneffort, LLC
K120437 02/13/2012 TWISTER SIDE-FIRE FIBER OPTIC DELIVERY SYSTEM BIOLITEC SIA (LATVIA)
K130681 03/13/2013 ENDOVASCULAR LASER VENOUS SYSTEM KIT WITH 2 RING RADIAL EMITTING FIBER BIOLITEC SIA
K100726 03/15/2010 CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM BIOLITEC, INC.
K101712 06/18/2010 ENDOVASCULAR LAER VEIN SYSTEM KIT BIOLITEC, INC.
K112013 07/14/2011 EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER BIOLITEC, INC.
K112253 08/05/2011 CERALAS 147NM DIODE LASER SYSTEM BIOLITEC, INC.
K112299 08/10/2011 ENDOVASCULAR LASER VEIN SYSTEM KIT BIOLITEC MEDICAL DEVICES, INC
K112324 08/12/2011 CERALAS 980NM DIODE LASER FAMILY BIOLITEC MEDICAL DEVICES, INC
K112442 08/24/2011 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC
K113688 12/15/2011 MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC
K113709 12/19/2011 MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE BIOLITEC MEDICAL DEVICES, INC
K113792 12/23/2011 MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE BIOLITEC MEDICAL DEVICES, INC
K113858 12/30/2011 MEGABEAM ENDO-ENT PROBE BIOLITEC MEDICAL DEVICES, INC
K120231 01/25/2012 EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL) BIOLITEC MEDICAL DEVICES, INC
K990015 01/04/1999 ELECTRODE NEEDLES TECHNOMED EUROPE
K964060 10/09/1996 COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE TRAVENOL LABORATORIES (ISRAEL) LTD.
K974171 11/05/1997 COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS TEVA MEDICAL, LTD.
K221409 05/16/2022 Paneffort 3-ply Surgical and Procedural Masks Paneffort, LLC
K072385 08/24/2007 HEARTEVENT, MODEL AT DIAGNOSTIC DEVICES PTY LTD
K113316 11/09/2011 DCS LACRIMAL STENT DCS SURGICAL INC
K071613 06/13/2007 AMIGO INSULIN PUMP NIPRO DIABETES SYSTEMS, INC.
K990389 02/08/1999 MOSS GASTROSTOMY TUBE MOSS TUBES, INC.
K984628 12/30/1998 MODIFICATION OF MOSS P.E.G. TRAY MOSS TUBES, INC.
K984629 12/30/1998 MOSS TUBES, INC. NASAL TUBE - MARK IV MOSS TUBES, INC.
K102114 07/28/2010 MEDRANGE ELECTROSURGICAL GENERATOR MEDRANGE CORPORATION
K954112 07/31/1995 VYGON LIFEVAC MID-LINE TRAY VYGON CORP.
K954302 09/13/1995 VYGON PREMI-CATH - LONG TERM CATHETER VYGON CORP.
K984310 12/02/1998 MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE MOSS TUBES, INC.
K983683 10/20/1998 UNIK TONGUE CLEANER UNIK PRODUCTS, INC.
K051357 05/24/2005 DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH DIGITIMER LTD.
K030218 01/21/2003 PER, MODEL MEMO MEDICAL MONITORS PTY., LTD.
K010751 03/13/2001 BPFONE, MODEL UA 767IT MEDICAL MONITORS PTY LIMITED
K071472 05/29/2007 PLANET 55 LARSEN & TOUBRO LIMITED
K061816 06/28/2006 GALAXY LARSEN & TOUBRO LIMITED


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