510(k) K153514
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 22, 2016
- Date Received
- December 7, 2015
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Activator, Ultraviolet, For Polymerization
- Device Class
- Class II
- Regulation Number
- 872.6070
- Review Panel
- DE
- Submission Type