510(k) K250864
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2025
- Date Received
- March 21, 2025
- 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
- Regulation Number
- Review Panel
- SU
- Submission Type