510(k) K200413
K200413 is an FDA 510(k) premarket notification submitted by Aroa Biosurgery , Ltd. for the device "Symphony". The FDA issued a decision of Substantially Equivalent on Jul 29, 2020. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Aroa Biosurgery , Ltd. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 29, 2020
- Date Received
- Feb 19, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Wound Dressing With Animal-Derived Material(S)
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)