FDA 510(k) Applications Submitted by RICHARD A HAMER

FDA 510(k) Number Submission Date Device Name Applicant
K912056 05/09/1991 GRAVITRON UPPER BODY SYSTEM EXERCISER TRI-TECH, INC.
K912057 05/09/1991 4000 PT EXERCISE SYSTEM TRI-TECH, INC.
K912140 05/14/1991 STAIRMASTER MODEL 6000 ERGOMETER TRI-TECH, INC.
K871643 04/27/1987 CONVEEN(R) LEG-BAG (600 ML) COLOPLAST A/S
K893379 05/01/1989 XENOS MOBILECAM XENOS MEDICAL SYSTEMS, INC.
K912058 05/09/1991 GAUNTLET STAIR CLIMBER TRI-TECH, INC.
K912761 06/24/1991 SURGICAL SAW BLADES BLAIRDEN PRECISION INSTRUMENTS, INC.
K894916 08/02/1989 COMFEEL TRANSPARENT DRESSING COLOPLAST A/S
K905438 12/04/1990 NORMLGEL PROTECTIVE WOUND GEL SCOTT HEALTH CARE
K905439 12/04/1990 HYPERGEL PROTECTIVE WOUND GEL SCOTT HEALTH CARE
K980117 01/13/1998 NUVO BARRIER FILM BIOMEDICAL DEVELOPMENT CO.
K990110 01/13/1999 DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140 MAERSK MEDICAL A/S
K990111 01/13/1999 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4520, 4535, 4570 MAERSK MEDICAL A/S
K990112 01/13/1999 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610 MAERSK MEDICAL A/S
K990113 01/13/1999 DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560 MAERSK MEDICAL A/S
K990115 01/13/1999 DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440 MAERSK MEDICAL A/S
K900404 01/29/1990 VARICOSCREEN(TM) PROMEDEX, INC.
K900421 01/30/1990 PROMISE ABSORBENT PROTECTIVE PAD SCOTT HEALTH CARE
K840438 02/01/1984 COMFEEL ULCUS SHEET COLOPLAST A/S
K060272 02/02/2006 LOCOBASE WOUND AND SKIN EMULSION FERNDALE LABORATORIES, INC.
K060340 02/10/2006 ORAMAGIC PLUS ORAL WOUND RINSE MPM MEDICAL, INC.
K890917 02/23/1989 PHOENIX DRAPES WITH MICROBAN PHOENIX MEDICAL TECHNOLOGY, INC.
K910857 02/28/1991 ALLDRESS MULTI LAYERED WOUND DRESSING SCOTT HEALTH CARE
K920925 02/28/1992 COMFEEL CONTOUR DRESSING COLOPLAST A/S
K950934 03/01/1995 MPM HYDROGEL DRESSING RICHARD HAMER ASSOC., INC.
K951325 03/23/1995 COMFEEL PLUS PRESSURE RELIEF DRESSING RICHARD HAMER ASSOC., INC.
K951327 03/23/1995 COMFEEL PLUS CONTOUR DRESSING RICHARD HAMER ASSOC., INC.
K951560 04/05/1995 RADIUS MANUAL WHWWLCHAIRS (COBRA, VIPER, SWING, OLYMPIA, AND MOBIL MODELS) RADIUS INTL., INC.
K881636 04/14/1988 CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) COLOPLAST A/S
K921810 04/15/1992 CURASOL(TM) WOUND DRESSING HEALTHSOUTH MEDICAL CENTER
K871610 04/24/1987 CONVEEN(R) NIGHT DRAINAGE BAG (2000 ML) COLOPLAST A/S
K881805 04/28/1988 TU STOPCOCK TULAN CORP. C/O RICHARD HAMER ASSOC.
K971597 05/01/1997 COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) COLOPLAST CORP.
K952113 05/05/1995 TBN-TIPPED OPTICAL FIBER MYRIADLASE, INC.
K893582 05/09/1989 N-A-G TEST KIT PPR DIAGNOSTICS LTD.
K942283 05/11/1994 COMFEEL PLUS TRANSPARENT DRESSING RICHARD HAMER ASSOC., INC.
K131396 05/15/2013 WIRED MOUTH PROTECTOR (WMP) ELBA LABORATORIES, INC.
K952300 05/16/1995 MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) MIDAS REX PNEUMATIC TOOLS, INC.
K852239 05/23/1985 POSICAM TM(MODEL 3.2,4.3,6.5) POSITION CORP.
K922461 05/26/1992 COMFEEL WOUND DRESSING ORD COLOPLAST A/S
K922466 05/26/1992 COMFEEL WOUND DRESSING SD COLOPLAST A/S
K942573 05/31/1994 COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH RICHARD HAMER ASSOC., INC.
K962160 06/04/1996 MPM HYDROGEL DRESSING (NON-STERILE) MPM MEDICAL, INC.
K942798 06/15/1994 MPM HYDROGEL MPM MEDICAL, INC.
K952733 06/15/1995 SIDEFIRE - TIPPED REUSABLE OPTICAL FIBERS MYRIADLASE, INC.
K972278 06/18/1997 CYTOPLAST REGENTEX TITANIUM 250 OSTEOGENICS CO.
K992074 06/18/1999 MPM REGENECARE WOUND GEL MPM MEDICAL, INC.
K962439 06/24/1996 DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) RICHARD HAMER ASSOC., INC.
K962513 06/27/1996 DERMAPLEX HYDROGEL WOUND DRESSING MAXXIM MEDICAL
K953450 07/18/1995 CURASOL GEL WOUND DRESSING DPT LABORATORIES, LTD.
K953433 07/21/1995 MIDAS REX TELESCOPING SYSTEM MIDAS REX PNEUMATIC TOOLS, INC.
K953434 07/21/1995 MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) MIDAS REX PNEUMATIC TOOLS, INC.
K953497 07/26/1995 COMFEEL:ALGINATE DRESSING COLOPLAST A/S
K092297 07/29/2009 ELETONE CREAM FERNDALE PHARMA GROUP, INC.
K962972 07/31/1996 SURGICADE GAUZE SPONGE ACCUNEX CANADA,INC.
K953816 08/15/1995 DCURASOL GEL WOUND DRESSING DPT LABORATORIES, LTD.
K883588 08/22/1988 COMPEED ATHLETIC DRESSING COLOPLAST A/S
K924406 08/25/1992 CONVEEN(R) LEG BAG(500 ML) COLOPLAST A/S
K924407 08/25/1992 CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH COLOPLAST A/S
K963388 08/28/1996 VESSEL DILATOR MAXXIM MEDICAL
K954076 08/30/1995 MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS MIDAS REX PNEUMATIC TOOLS, INC.
K904085 09/05/1990 ELLA BREAST FORM COLOPLAST A/S
K904086 09/05/1990 DISCRENE SELF-SUPPORTING BREAST FORM COLOPLAST A/S
K873669 09/11/1987 COMFEEL ULCUS ULCER CARE SYSTEM COLOPLAST A/S
K895548 09/13/1989 CONVEEN INTERMITTENT CATHETERS COLOPLAST A/S
K963749 09/18/1996 HIGH PRESSURE INJECTION LINES MAXXIM MEDICAL
K863830 09/30/1986 CONSEAL(TM) COLOSTOMY CONTINENCE SYSTEM COLOPLAST A/S
K914407 10/02/1991 PROMOGLASS(TM) SUNGLASSES (NON-PRESCRIPTION) PROMEDEX, INC.
K934839 10/08/1993 MESALT STERILE DRESSING RICHARD HAMER ASSOC., INC.
K945068 10/14/1994 OMEGA CARES SYSTEM J-F MEDICAL SYSTEMS INTL., INC.
K925376 10/23/1992 COMFEEL(R) WOUND DRESSING SD COLOPLAST A/S
K954857 10/23/1995 COMFEEL:ALGINATE FILLER COLOPLAST CORP.
K993610 10/25/1999 CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 OSTEOGENICS BIOMEDICAL, INC.
K935207 10/29/1993 ENDOFLUSH SYSTEM 1.0, 2.O, 3.0 SPECIALTY MEDICAL SYSTEMS, INC.
K964342 10/31/1996 CYTOPLAST GBR OSTEOGENICS CO.
K935298 11/02/1993 INSTA-NERVE(TM) NERVE CONDUCTION MONITOR INSTA NERVE CANADA, INC.
K013764 11/13/2001 IMMIX BONE GRAFT EXTENDER OSTEOGENICS BIOMEDICAL, INC.
K915246 11/15/1991 CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) COLOPLAST A/S
K964634 11/19/1996 ANOKRYO MK CONQUEST INTL., INC.
K984230 11/25/1998 OSTEO-MESH TM-300 OSTEOGENICS BIOMEDICAL, INC.
K926044 12/01/1992 MPM WET DRESSING (SALINE) MPM MEDICAL, INC.
K003720 12/04/2000 ANGEL OF WATER COLON HYDROTHERAPY SYSTEM LIFESTREAM PURFICATION SYSTEMS, LLC.
K003804 12/08/2000 SENSI-PREMA NEONATAL ECG ELECTRODES, 40612,40614,40626,40550,40554,40555,440556,40610,40613,40625,40801 NIKO MEDICAL PRODUCTS
K024180 12/18/2002 ORAMAGICRX ORAL WOUND RINSE MPM MEDICAL, INC.
K946243 12/22/1994 CONVEEN(R) SELF-SEALING URISHEATH MALE EXTERNAL CATHETER COLOPLAST A/S
K965120 12/23/1996 ALLCLENZ WOUND CLEANSER DPT LABORATORIES, LTD.
K965180 12/24/1996 STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) MYRIADLASE, INC.
K897142 12/27/1989 MESALT STERILE DRESSING SCOTT HEALTH CARE
K905764 12/27/1990 SEMINOR PROMEDEX, INC.
K955863 12/27/1995 ALLDRESS MULTI LAYERED WOUND DRESSING MOLNLYCKE/SCOTT HEALTH CARE
K955872 12/28/1995 VOLMED OPERATION DRAPE MEDAL INTL. SALES CO., LLC.


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