K140510 is an FDA 510(k) clearance for the MIROMATRIX WOUND MATRIX, a Wound Dressing With Animal-derived Material(s), submitted by Miromatrix Medical, Inc. (Alexandria, US). The FDA issued a Cleared decision on June 19, 2014, 111 days after receiving the submission on February 28, 2014. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K140510 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 28, 2014 |
| Decision Date | June 19, 2014 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |