510(k) K161922
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2016
- Date Received
- July 13, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Powder, Porcelain
- Device Class
- Class II
- Regulation Number
- 872.6660
- Review Panel
- DE
- Submission Type