K030921 is an FDA 510(k) clearance for the COLLAGEN TOPICAL WOUND DRESSING. This device is classified as a Wound Dressing With Animal-derived Material(s).
Submitted by Collagen Matrix, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on May 15, 2003, 52 days after receiving the submission on March 24, 2003.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K030921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 24, 2003 |
| Decision Date | May 15, 2003 |
| Days to Decision | 52 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 | — |