K102943 is an FDA 510(k) clearance for the CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050, a Dressing, Wound, Drug, submitted by Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on April 12, 2011, 190 days after receiving the submission on October 4, 2010. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K102943 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 04, 2010 |
| Decision Date | April 12, 2011 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |