The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Polypropylene Hernia Mesh.
| Device ID | K043081 |
| 510k Number | K043081 |
| Device Name: | GORE POLYPROPYLENE HERNIA MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2004-12-22 |
| Summary: | summary |