The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Titanium Mesh Maxillofacial Implant System.
| Device ID | K896369 |
| 510k Number | K896369 |
| Device Name: | TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM |
| Classification | Mesh, Surgical, Metal |
| Applicant | TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Contact | Gary Kelsey |
| Correspondent | Gary Kelsey TECHMEDICA, INC. 1380 FLYNN RD. Camarillo, CA 93010 |
| Product Code | EZX |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1989-11-24 |