510(k) K780174
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1978
- Date Received
- February 2, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Denture, Mechanical
- Device Class
- Class I
- Regulation Number
- 872.3530
- Review Panel
- DE
- Submission Type