K160379 is an FDA 510(k) clearance for the Exufiber Ag+. This device is classified as a Dressing, Wound, Drug.
Submitted by Molnlycke Health Care Us, LLC (Norcross, US). The FDA issued a Cleared decision on August 25, 2016, 197 days after receiving the submission on February 10, 2016.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K160379 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2016 |
| Decision Date | August 25, 2016 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |