K111578 is an FDA 510(k) clearance for the CORELEADER COLLA-ALGI FIBER MODEL CAW, a Dressing, Wound, Drug, submitted by Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on September 23, 2011, 108 days after receiving the submission on June 7, 2011. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K111578 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 07, 2011 |
| Decision Date | September 23, 2011 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |