K023138 is an FDA 510(k) clearance for the HYDROFERA BACTERIOSTATIC WOUND DRESSING, a Dressing, Wound, Drug, submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on January 17, 2003, 119 days after receiving the submission on September 20, 2002. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K023138 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 20, 2002 |
| Decision Date | January 17, 2003 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |