K021637 is an FDA 510(k) clearance for the ACELL UBM LYOPHILIZED WOUND DRESSING, a Wound Dressing With Animal-derived Material(s), submitted by Acell, Inc. (Washington, US). The FDA issued a Cleared decision on December 19, 2002, 216 days after receiving the submission on May 17, 2002. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K021637 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 17, 2002 |
| Decision Date | December 19, 2002 |
| Days to Decision | 216 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 | — |