510(k) K780528
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 1978
- Date Received
- April 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Carver, Dental Amalgam, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type