K022127 is an FDA 510(k) clearance for the AVAGEN WOUND DRESSING, a Wound Dressing With Animal-derived Material(s), submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on September 10, 2002, 71 days after receiving the submission on July 1, 2002. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K022127 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 01, 2002 |
| Decision Date | September 10, 2002 |
| Days to Decision | 71 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 | — |