K190268 is an FDA 510(k) clearance for the Hydrofera Blue READY - Border, a Dressing, Wound, Drug, submitted by Hydrofera, LLC (Manchester, US). The FDA issued a Cleared decision on November 6, 2019, 271 days after receiving the submission on February 8, 2019. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K190268 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 08, 2019 |
| Decision Date | November 06, 2019 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |