K133542 is an FDA 510(k) clearance for the PURACYN PLUS SKIN AND WOUND, a Dressing, Wound, Drug, submitted by Innovacyn, Inc. (Rialto, US). The FDA issued a Cleared decision on April 28, 2014, 161 days after receiving the submission on November 18, 2013. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K133542 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2013 |
| Decision Date | April 28, 2014 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |