510(k) K082158
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2008
- Date Received
- July 31, 2008
- 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