510(k) K830116
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1983
- Date Received
- January 11, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Retractor, Dental
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type