K102946 is an FDA 510(k) clearance for the CORELEADER COLLA-PAD MODEL CS 03030, a Wound Dressing With Animal-derived Material(s), submitted by Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on May 20, 2011, 228 days after receiving the submission on October 4, 2010. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K102946 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 04, 2010 |
| Decision Date | May 20, 2011 |
| Days to Decision | 228 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 | — |