K131286 is an FDA 510(k) clearance for the PRIMATRIX DERMAL REPAIR SCAFFOLD. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on August 5, 2013, 91 days after receiving the submission on May 6, 2013.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K131286 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 2013 |
| Decision Date | August 05, 2013 |
| Days to Decision | 91 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 | — |