The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex Dualmesh Plus Biomaterial With Holes.
| Device ID | K010228 |
| 510k Number | K010228 |
| Device Name: | GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | R. Larry Pratt |
| Correspondent | R. Larry Pratt W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-24 |
| Decision Date | 2001-02-21 |