K040868 is an FDA 510(k) clearance for the SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH. This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on June 4, 2004, 63 days after receiving the submission on April 2, 2004.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K040868 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2004 |
| Decision Date | June 04, 2004 |
| Days to Decision | 63 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 |