FDA 510(k) Applications Submitted by NORMAN F ESTRIN
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K992630 |
06/15/1999 |
THERMALIGHT 2000 |
JENNIFERMAXX, INC. |
| K080114 |
01/16/2008 |
HUAYI H035 BASIC WHEELCHAIR |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
| K030177 |
01/17/2003 |
ORLON NONABSORABLE SURGICAL SUTURE USP |
SRI ORION PHARMACEUTICALS & SUTURES |
| K080207 |
01/28/2008 |
DANYANG HUAYI K2 AND K7 WHEELCHAIRS |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
| K050279 |
02/07/2005 |
AXS-1 LITE WHEELCHAIR |
ACCESS POINT MEDICAL, L.L.C. |
| K050280 |
02/07/2005 |
RUNABOUT WHEELCHAIR |
ACCESS POINT MEDICAL, L.L.C. |
| K050281 |
02/07/2005 |
TRANSPORT SERIES TRANSPORT CHAIR |
ACCESS POINT MEDICAL, L.L.C. |
| K110468 |
02/17/2011 |
FREEWAY COMFORT BITE GUARD |
RANDMARK DENTAL PRODUCTS, LLC |
| K990622 |
02/25/1999 |
BOLD SCREW |
NEWDEAL S.A. |
| K001231 |
04/17/2000 |
THE KALIX IMPLANT |
NEWDEAL S.A. |
| K071088 |
04/18/2007 |
LIFE LATCH SHARPS & BIOHAZARD CONTAINER |
M&M INDUSTRIES, INC. |
| K011262 |
04/25/2001 |
MODIFICATION TO THE BOLD SCREW |
NEWDEAL S.A. |
| K991477 |
04/28/1999 |
SPIN SNAP-OFF SCREW |
NEWDEAL S.A. |
| K991482 |
04/28/1999 |
UNI-CLIP STAPLE |
NEWDEAL S.A. |
| K961732 |
05/03/1996 |
KAR |
LANDOS, INC. |
| K991566 |
05/05/1999 |
SOLUSTAPLE |
NEWDEAL S.A. |
| K021626 |
05/17/2002 |
HALLU PLATES |
NEWDEAL S.A. |
| K031617 |
05/23/2003 |
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER |
MEDIPLUS LTD. |
| K011716 |
06/04/2001 |
THE UNI-CLIP STAPLE |
NEWDEAL S.A. |
| K962233 |
06/11/1996 |
TWIST-OFF SCREW |
LANDOS, INC. |
| K962236 |
06/11/1996 |
SCARF THREAD-HEAD SCREW |
LANDOS, INC. |
| K011821 |
06/11/2001 |
MODIFICATION TO THE I.C.O.S SCREW |
NEWDEAL S.A. |
| K041601 |
06/14/2004 |
SURFIX KNEE OSTEOTOMY SYSTEM |
SURFIX TECHNOLOGIES |
| K011946 |
06/21/2001 |
THE SPIN SNAP-OFF SCREW |
NEW DEAL, S.A. |
| K953111 |
07/03/1995 |
CORAIL |
LANDOS, INC. |
| K101894 |
07/07/2010 |
HEALTHLIGHT MICROCONTROLLER, MINIPRO, PRONEUROLIGHT, AND PRO UNIT |
BIOREMEDI THERAPEUTIC SYSTEMS, INC |
| K141919 |
07/15/2014 |
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR |
AD REM TECHNOLOGY SARL |
| K042038 |
07/29/2004 |
MTF ALLOGRAFT ANCHOR |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
| K022597 |
08/05/2002 |
K-FIX |
NEWDEAL S.A. |
| K022599 |
08/05/2002 |
NEWDEAL K WIRE |
NEWDEAL S.A. |
| K072252 |
08/13/2007 |
VEINOPLUS NEUROMUSCULAR STIMULATOR |
ADREM TECHNOLOGY SARL |
| K993762 |
11/08/1999 |
I.CO.S SCREW |
NEWDEAL S.A. |
| K993764 |
11/08/1999 |
MEDIPACK SEE-THROUGH SEAL STERILIZATION POUCH |
MEDIPACK MEDICAL PACKAGING MFG. CO. |
| K993910 |
11/17/1999 |
TAC' PIN |
NEWDEAL S.A. |
| K083559 |
12/02/2008 |
YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B |
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
| K131920 |
06/26/2013 |
STABILIZATION SCREW |
IN2BONES SAS |
| K132912 |
09/17/2013 |
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT |
IN2BONES SAS |
| K964522 |
11/12/1996 |
ELLIPSE 4 |
ANDROMEDA MEDIZINISCHE SYSTEME GMBH |
| K964226 |
10/23/1996 |
MEMORY STAPLE (20 SIZES AVAILABLE) |
LANDOS, INC. |
| K080216 |
01/29/2008 |
SUPRAMESH EXTRA |
S. JACKSON, INC. |
| K972918 |
08/07/1997 |
RAPID FIRE HAIR IMPLANTER CAROUSEL |
APEX MEDICAL PRODUCTS, LLC. |
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