K130670 is an FDA 510(k) clearance for the HYDROFERA BLUE PU BACTERIOSTATIC DRESSING, a Dressing, Wound, Drug, submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on January 2, 2014, 296 days after receiving the submission on March 12, 2013. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K130670 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 12, 2013 |
| Decision Date | January 02, 2014 |
| Days to Decision | 296 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |