510(k) K181597
K181597 is an FDA 510(k) premarket notification submitted by Kmihh, Ltd. for the device "Le'Pen". The FDA issued a decision of Substantially Equivalent on Apr 1, 2019. The device falls under product code EBZ (Activator, Ultraviolet, For Polymerization), a Class II device regulated under 21 CFR 872.6070.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 1, 2019
- Date Received
- Jun 18, 2018
- 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
- 510(k)