FDA 510(k) Applications Submitted by RICHARD A HAMER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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 |
| K060272 |
02/02/2006 |
LOCOBASE WOUND AND SKIN EMULSION |
FERNDALE LABORATORIES, INC. |
| K060340 |
02/10/2006 |
ORAMAGIC PLUS ORAL WOUND RINSE |
MPM MEDICAL, INC. |
| K971597 |
05/01/1997 |
COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) |
COLOPLAST CORP. |
| K131396 |
05/15/2013 |
WIRED MOUTH PROTECTOR (WMP) |
ELBA LABORATORIES, INC. |
| K962160 |
06/04/1996 |
MPM HYDROGEL DRESSING (NON-STERILE) |
MPM MEDICAL, 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 |
| K953434 |
07/21/1995 |
MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) |
MIDAS REX PNEUMATIC TOOLS, INC. |
| K092297 |
07/29/2009 |
ELETONE CREAM |
FERNDALE PHARMA GROUP, INC. |
| K962972 |
07/31/1996 |
SURGICADE GAUZE SPONGE |
ACCUNEX CANADA,INC. |
| K963388 |
08/28/1996 |
VESSEL DILATOR |
MAXXIM MEDICAL |
| K963749 |
09/18/1996 |
HIGH PRESSURE INJECTION LINES |
MAXXIM MEDICAL |
| K945068 |
10/14/1994 |
OMEGA CARES SYSTEM |
J-F MEDICAL SYSTEMS INTL., INC. |
| K993610 |
10/25/1999 |
CYTOPLAST RESORB, MODELS R-250, RP-250, RU-250, RPS-250, RPL-250 |
OSTEOGENICS BIOMEDICAL, INC. |
| K964342 |
10/31/1996 |
CYTOPLAST GBR |
OSTEOGENICS CO. |
| K013764 |
11/13/2001 |
IMMIX BONE GRAFT EXTENDER |
OSTEOGENICS BIOMEDICAL, INC. |
| K964634 |
11/19/1996 |
ANOKRYO |
MK CONQUEST INTL., INC. |
| K984230 |
11/25/1998 |
OSTEO-MESH TM-300 |
OSTEOGENICS BIOMEDICAL, 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. |
| K965120 |
12/23/1996 |
ALLCLENZ WOUND CLEANSER |
DPT LABORATORIES, LTD. |
| K965180 |
12/24/1996 |
STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000) |
MYRIADLASE, 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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