510(k) K201631
K201631 is an FDA 510(k) premarket notification submitted by Alafair Biosciences, Inc. for the device "VersaWrap Nerve Protector". The FDA issued a decision of Substantially Equivalent on September 14, 2020. The device falls under product code JXI (Cuff, Nerve), a Class II device regulated under 21 CFR 882.5275. Alafair Biosciences, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2020
- Date Received
- June 16, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cuff, Nerve
- Device Class
- Class II
- Regulation Number
- 882.5275
- Review Panel
- NE
- Submission Type