The following data is part of a premarket notification filed by Evera Medical, Inc. with the FDA for Facial Reconstructive Mesh (frm).
| Device ID | K063154 |
| 510k Number | K063154 |
| Device Name: | FACIAL RECONSTRUCTIVE MESH (FRM) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | EVERA MEDICAL, INC. 353 VINTAGE PARK DRIVE SUITE F Foster City, CA 94404 |
| Contact | Randy Kesten |
| Correspondent | Randy Kesten EVERA MEDICAL, INC. 353 VINTAGE PARK DRIVE SUITE F Foster City, CA 94404 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-16 |
| Decision Date | 2007-07-10 |
| Summary: | summary |