510(k) K260859
K260859 is an FDA 510(k) premarket notification submitted by Hass Corp. for the device "Rosetta SM, Rosetta SP". The FDA issued a decision of Substantially Equivalent on June 11, 2026. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Hass Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 11, 2026
- Date Received
- March 16, 2026
- 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