510(k) K201577
K201577 is an FDA 510(k) premarket notification submitted by Medskin Solutions Dr. Suwelack AG for the device "MatriDerm". The FDA issued a decision of Substantially Equivalent on January 7, 2021. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Medskin Solutions Dr. Suwelack AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 2021
- Date Received
- June 11, 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
- Regulation Number
- Review Panel
- SU
- Submission Type