K081635 is an FDA 510(k) clearance for the INTEGRA MESHED BILAYER WOUND MATRIX, a Wound Dressing With Animal-derived Material(s), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on December 4, 2008, 176 days after receiving the submission on June 11, 2008. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K081635 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 11, 2008 |
| Decision Date | December 04, 2008 |
| Days to Decision | 176 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 | — |