510(k) K040098
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 4, 2004
- Date Received
- January 20, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Varnish, Cavity
- Device Class
- Class II
- Regulation Number
- 872.3260
- Review Panel
- DE
- Submission Type