K110663 is an FDA 510(k) clearance for the PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES). This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Sofradim Production (Bedford, US). The FDA issued a Cleared decision on August 11, 2011, 156 days after receiving the submission on March 8, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K110663 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 2011 |
| Decision Date | August 11, 2011 |
| Days to Decision | 156 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 |