510(k) K200918
K200918 is an FDA 510(k) premarket notification submitted by Mast Biosurgery for the device "SurgiWrap FROST". The FDA issued a decision of Substantially Equivalent on Jan 7, 2021. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. Mast Biosurgery has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 7, 2021
- Date Received
- Apr 6, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
- 510(k)