K083039 is an FDA 510(k) clearance for the VERITAS COLLAGEN MATRIX (DRY), a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Synovis Surgical Innovations (St. Paul, US). The FDA issued a Cleared decision on November 26, 2008, 43 days after receiving the submission on October 14, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K083039 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 14, 2008 |
| Decision Date | November 26, 2008 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |