510(k) K200311
K200311 is an FDA 510(k) premarket notification submitted by Alafair Biosciences, Inc. for the device "VersaWrap Tendon Protector". The FDA issued a decision of Substantially Equivalent on March 6, 2020. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Alafair Biosciences, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 2020
- Date Received
- February 6, 2020
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type