K100261 is an FDA 510(k) clearance for the PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD. This device is classified as a Dressing, Wound, Drug.
Submitted by Tei Biosciences, Inc. (Boston, US). The FDA issued a Cleared decision on December 10, 2010, 316 days after receiving the submission on January 28, 2010.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K100261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2010 |
| Decision Date | December 10, 2010 |
| Days to Decision | 316 days |
| Submission Type | Abbreviated |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |