510(k) K192251
K192251 is an FDA 510(k) premarket notification submitted by Cendres+Metaux SA for the device "Livento Press, Soprano 10, Soprano". The FDA issued a decision of Substantially Equivalent on Jan 15, 2020. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Cendres+Metaux SA has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 15, 2020
- Date Received
- Aug 20, 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)