510(k) K051545
K051545 is an FDA 510(k) premarket notification submitted by Kerr Corporation (Danbury) for the device "L.E. DEMETRON II". The FDA issued a decision of Substantially Equivalent on July 18, 2005. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070. Kerr Corporation (Danbury) has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2005
- Date Received
- June 10, 2005
- 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