The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Dualmesh Biomaterial With Holes.
| Device ID | K955494 |
| 510k Number | K955494 |
| Device Name: | GORE-TEX DUALMESH BIOMATERIAL WITH HOLES |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 W. KILTIE LN. Flagstaff, AZ 86001 -0900 |
| Contact | John W Nicholson |
| Correspondent | John W Nicholson W.L. GORE & ASSOCIATES,INC 3750 W. KILTIE LN. 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 | 1995-12-01 |
| Decision Date | 1996-01-24 |