K112409 is an FDA 510(k) clearance for the MATRISTEM WOUND MATRIX. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Acell, Inc. (Columbia, US). The FDA issued a Cleared decision on August 29, 2011, 7 days after receiving the submission on August 22, 2011.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K112409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2011 |
| Decision Date | August 29, 2011 |
| Days to Decision | 7 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 | — |