K041669 is an FDA 510(k) clearance for the VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD, 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 October 27, 2004, 128 days after receiving the submission on June 21, 2004. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K041669 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 21, 2004 |
| Decision Date | October 27, 2004 |
| Days to Decision | 128 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 |