K061407 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 June 29, 2006, 38 days after receiving the submission on May 22, 2006.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K061407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2006 |
| Decision Date | June 29, 2006 |
| Days to Decision | 38 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |