FDA 510(k) Applications Submitted by MARY E GRAY
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K021019 |
03/29/2002 |
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE |
GENZYME CORP. |
| K061520 |
06/02/2006 |
VIPER SPINE SYSTEM |
DEPUY SPINE, INC. |
| K062174 |
07/31/2006 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K062196 |
08/01/2006 |
SFX SNAP-FIT CROSS CONNECTOR |
DEPUY SPINE, INC. |
| K032563 |
08/20/2003 |
CLINITEST HCG PREGNANCY TEST |
BAYER HEALTHCARE, LLC |
| K980081 |
01/09/1998 |
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K980801 |
03/02/1998 |
J-FX BIPOLAR HEAD |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K991191 |
04/08/1999 |
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K001434 |
05/08/2000 |
'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K001440 |
05/08/2000 |
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K031560 |
05/19/2003 |
BAYER RAPIDLAB 1200 SYSTEM |
BAYER HEALTHCARE, LLC |
| K992088 |
06/21/1999 |
BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE |
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) |
| K031947 |
06/24/2003 |
BAYER CLINITEK STATUS ANALYZER |
BAYER HEALTHCARE, LLC |
| K972435 |
06/30/1997 |
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K982812 |
08/11/1998 |
G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K973307 |
09/03/1997 |
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD |
JOHNSON & JOHNSON PROFESSIONALS, INC. |
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