K134033 is an FDA 510(k) clearance for the MIROMATRIX BIOLOGICAL MESH, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Miromatrix Medical, Inc. (Alexandria, US). The FDA issued a Cleared decision on March 31, 2014, 90 days after receiving the submission on December 31, 2013. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K134033 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 31, 2013 |
| Decision Date | March 31, 2014 |
| Days to Decision | 90 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 |