K253974
- 510(k) number
- K253974
- Device name
- Roosin Collagen Dressing
- Applicant
- Roosin Medical Co., Ltd. CN
- Product code
- KGN — Wound Dressing With Animal-Derived Material(S)
- Decision date
- 2026-06-03
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K253974.pdf
Official FDA record: K253974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.