K091499 is an FDA 510(k) clearance for the MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY). This device is classified as a Mesh, Surgical (Class II - Special Controls, product code FTM).
Submitted by Kensey Nash Corp. (Exton, US). The FDA issued a Cleared decision on October 22, 2009, 154 days after receiving the submission on May 21, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K091499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2009 |
| Decision Date | October 22, 2009 |
| Days to Decision | 154 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 |