510(k) K082971
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2008
- Date Received
- October 6, 2008
- Clearance Type
- Traditional
- 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