K153690 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 February 22, 2016, 61 days after receiving the submission on December 23, 2015.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K153690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2015 |
| Decision Date | February 22, 2016 |
| Days to Decision | 61 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 | — |