The following data is part of a premarket notification filed by Synovis Surgical Innovations with the FDA for Synovis Collagen Matrix (tbd).
| Device ID | K122306 |
| 510k Number | K122306 |
| Device Name: | SYNOVIS COLLAGEN MATRIX (TBD) |
| Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
| 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 | DXZ |
| CFR Regulation Number | 870.3470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2013-03-08 |
| Summary: | summary |