The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Tornier Surgical Mesh.
| Device ID | K093799 |
| 510k Number | K093799 |
| Device Name: | TORNIER SURGICAL MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-10 |
| Decision Date | 2010-04-22 |
| Summary: | summary |