K062558 is an FDA 510(k) clearance for the MESOSFOL SURGICAL FILM. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on June 20, 2007, 294 days after receiving the submission on August 30, 2006.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K062558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 30, 2006 |
| Decision Date | June 20, 2007 |
| Days to Decision | 294 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 |