K200413 is an FDA 510(k) clearance for the Symphony, a Wound Dressing With Animal-derived Material(s), submitted by Aroa Biosurgery , Ltd. (Airport Oaks, NZ). The FDA issued a Cleared decision on July 29, 2020, 161 days after receiving the submission on February 19, 2020. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K200413 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 2020 |
| Decision Date | July 29, 2020 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KGN — Wound Dressing With Animal-derived Material(s) |
| Device Class | — |