The following data is part of a premarket notification filed by Synovis Surgical Innovations with the FDA for Veritas Collagen Matrix (dry).
| Device ID | K083039 |
| 510k Number | K083039 |
| Device Name: | VERITAS COLLAGEN MATRIX (DRY) |
| Classification | Mesh, Surgical |
| Applicant | SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. WEST St. Paul, MN 55114 -1024 |
| Contact | Jodi Jorgenson |
| Correspondent | Jodi Jorgenson SYNOVIS SURGICAL INNOVATIONS 2575 UNIVERSITY AVE. WEST St. Paul, MN 55114 -1024 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2008-11-26 |
| Summary: | summary |