510(k) K253974
K253974 is an FDA 510(k) premarket notification submitted by Roosin Medical Co., Ltd. for the device "Roosin Collagen Dressing". The FDA issued a decision of Substantially Equivalent on June 3, 2026. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Roosin Medical Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 2026
- Date Received
- December 11, 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