The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Soft Tissue Patch,mycromesha Biomaterial,dualmesh Biomaterial,dualmesh Biomaterial With Holes.
| Device ID | K963619 |
| 510k Number | K963619 |
| Device Name: | GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 W. KILTIE Flagstaff, AZ 86001 -0900 |
| Contact | John W Nicholson |
| Correspondent | John W Nicholson W.L. GORE & ASSOCIATES,INC 3750 W. KILTIE Flagstaff, AZ 86001 -0900 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-10 |
| Decision Date | 1996-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132600625 | K963619 | 000 |
| 00733132600502 | K963619 | 000 |
| 00733132600519 | K963619 | 000 |
| 00733132600526 | K963619 | 000 |
| 00733132600533 | K963619 | 000 |
| 00733132600540 | K963619 | 000 |
| 00733132600564 | K963619 | 000 |
| 00733132600571 | K963619 | 000 |
| 00733132600588 | K963619 | 000 |
| 00733132600595 | K963619 | 000 |
| 00733132600601 | K963619 | 000 |
| 00733132600618 | K963619 | 000 |
| 00733132600489 | K963619 | 000 |