The following data is part of a premarket notification filed by Synovis Surgical Innovations with the FDA for Veritas Collagen Matrix.
| Device ID | K062915 |
| 510k Number | K062915 |
| Device Name: | VERITAS COLLAGEN MATRIX |
| Classification | Mesh, Surgical |
| Applicant | SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Contact | Cynthia Lamarucciola |
| Correspondent | Cynthia Lamarucciola SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. St. Paul, MN 55114 -1024 |
| Product Code | FTM |
| Subsequent Product Code | OXB |
| Subsequent Product Code | OXE |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-27 |
| Decision Date | 2006-12-06 |
| Summary: | summary |