K080452 is an FDA 510(k) clearance for the COLLAGEN TENDON WRAP. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on May 15, 2008, 86 days after receiving the submission on February 19, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K080452 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2008 |
| Decision Date | May 15, 2008 |
| Days to Decision | 86 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 |