K053066 is an FDA 510(k) clearance for the SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH, a Mesh, Surgical, Polymeric (Class II — Special Controls, product code FTL), submitted by Genzyme Corporation (Cambridge, US). The FDA issued a Cleared decision on December 19, 2005, 48 days after receiving the submission on November 1, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K053066 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 2005 |
| Decision Date | December 19, 2005 |
| Days to Decision | 48 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |