510(k) K031809
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2004
- Date Received
- June 12, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Fluoride, Disposable
- Device Class
- Class I
- Regulation Number
- 872.6870
- Review Panel
- DE
- Submission Type