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 Plus.
| Device ID | K922452 |
| 510k Number | K922452 |
| Device Name: | GORE-TEX SOFT TISSUE PATCH PLUS |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. DOCK-A P.O. BOX 900 Flagstaff, AR 86002 |
| Contact | Thom O'hara |
| Correspondent | Thom O'hara W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LN. DOCK-A P.O. BOX 900 Flagstaff, AR 86002 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-26 |
| Decision Date | 1994-09-29 |