K082748 is an FDA 510(k) clearance for the ATRIUM PROLITE S MESH. This device is classified as a Mesh, Surgical, Polymeric (Class II - Special Controls, product code FTL).
Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on January 14, 2009, 117 days after receiving the submission on September 19, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K082748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 2008 |
| Decision Date | January 14, 2009 |
| Days to Decision | 117 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FTL — Mesh, Surgical, Polymeric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3300 |