The following data is part of a premarket notification filed by Ti-mesh, Inc. with the FDA for Tilghman Titanium Mesh Skeletal Orbit Liner.
| Device ID | K922308 |
| 510k Number | K922308 |
| Device Name: | TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER |
| Classification | Mesh, Surgical |
| Applicant | TI-MESH, INC. 76 SPECTRUM RD. Las Vegas, NV 89101 |
| Contact | Mary P Morgan |
| Correspondent | Mary P Morgan TI-MESH, INC. 76 SPECTRUM RD. Las Vegas, NV 89101 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1993-01-12 |