510(k) K833038
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 4, 1983
- Date Received
- September 6, 1983
- 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