The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Infinit Mesh.
| Device ID | K081069 |
| 510k Number | K081069 |
| Device Name: | GORE INFINIT MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD. Elkton, MD 21921 |
| Contact | Michael J Titus |
| Correspondent | Michael J Titus W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD. Elkton, MD 21921 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-15 |
| Decision Date | 2008-05-30 |
| Summary: | summary |