K040403 is an FDA 510(k) clearance for the COLLAGEN WOUND DRESSING - ORAL. 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 10, 2004, 83 days after receiving the submission on February 17, 2004.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K040403 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 17, 2004 |
| Decision Date | May 10, 2004 |
| Days to Decision | 83 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 | — |