510(k) K802984
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1980
- Date Received
- November 21, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Diamond, Dental
- Device Class
- Class I
- Regulation Number
- 872.4535
- Review Panel
- DE
- Submission Type