510(k) K160377
K160377 is an FDA 510(k) premarket notification submitted by Vericom Co., Ltd. for the device "V-varnish Premium". The FDA issued a decision of Substantially Equivalent on December 2, 2016. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Vericom Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 2016
- Date Received
- February 10, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type