K250864
- 510(k) number
- K250864
- Device name
- MatriDerm pluS+ Bi-Layer
- Applicant
- Medskin Solutions Dr. Suwelack AG DE
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2025-12-19
- Date received
- 2025-03-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250864.pdf
Official FDA record: K250864
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.