510(k) K160102
K160102 is an FDA 510(k) premarket notification submitted by Hass Corp. for the device "Amber Mill Series and Amber Press Series". The FDA issued a decision of Substantially Equivalent on July 14, 2016. 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
- July 14, 2016
- Date Received
- January 19, 2016
- 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