K150799 is an FDA 510(k) clearance for the Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula, a Dressing, Wound, Drug, submitted by Innovacyn, Inc. (Rialto, US). The FDA issued a Cleared decision on November 19, 2015, 238 days after receiving the submission on March 26, 2015. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K150799 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 26, 2015 |
| Decision Date | November 19, 2015 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |