FDA 510(k) Applications Submitted by TEENA M AUGOSTINO
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K960706 |
02/21/1996 |
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT |
CARBOMEDICS, INC. |
| K963611 |
09/10/1996 |
VASCUTEK CARDIOVASCULAR FABRIC: VASCUTEK GELSEAL PATCH,VASCUTEK GELSOFT PATCH,VASCUTEK THIN WALL CAROTID PATCH |
VASCUTEK LTD. |
| K983258 |
09/16/1998 |
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
| K983260 |
09/16/1998 |
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
| K973586 |
09/22/1997 |
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II |
SPINAL CONCEPTS, INC. |
| K973687 |
09/26/1997 |
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM |
SPINAL CONCEPTS, INC. |
| K974020 |
10/22/1997 |
SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM |
SPINAL CONCEPTS, INC. |
| K955230 |
11/14/1995 |
VASCUTEK GELSOFT PLUS VASCULAR GRAFT |
VASCUTEK LTD. |
| K964665 |
11/21/1996 |
VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION) |
CARBOMEDICS, INC. |
| K964959 |
12/11/1996 |
VASCUTEK TWILLWEAVE VASCULAR GRAFT |
VASCUTEK LTD. |
|
|
