510(k) K140481
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2014
- Date Received
- February 26, 2014
- 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