K141382 is an FDA 510(k) clearance for the BIOS KING BIOCELLULOSE FILM, a Dressing, Wound, Drug, submitted by Coreleader Biotech Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on February 10, 2015, 259 days after receiving the submission on May 27, 2014. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K141382 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 27, 2014 |
| Decision Date | February 10, 2015 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |