K013462 is an FDA 510(k) clearance for the HYDROFERA BACTERIOSTATIC WOUND DRESSING. This device is classified as a Dressing, Wound, Drug.
Submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on January 11, 2002, 85 days after receiving the submission on October 18, 2001.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K013462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 18, 2001 |
| Decision Date | January 11, 2002 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |