K103568 is an FDA 510(k) clearance for the RESTORELLE POLYPROPYLENE MESH. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on December 22, 2010, 16 days after receiving the submission on December 6, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K103568 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2010 |
| Decision Date | December 22, 2010 |
| Days to Decision | 16 days |
| Submission Type | Special |
| 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 |