510(k) K102128
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2010
- Date Received
- July 29, 2010
- Clearance Type
- Abbreviated
- 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