510(k) K191902
K191902 is an FDA 510(k) premarket notification submitted by U&C International Co., Ltd. for the device "Razor, Everest, U&C Liquid". The FDA issued a decision of Substantially Equivalent on Oct 11, 2019. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 11, 2019
- Date Received
- Jul 16, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type
- 510(k)