510(k) K931162
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1993
- Date Received
- March 8, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Denture, Plastic, Teeth
- Device Class
- Class II
- Regulation Number
- 872.3590
- Review Panel
- DE
- Submission Type