510(k) K974035
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 1997
- Date Received
- October 24, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alloy, Amalgam
- Device Class
- Class II
- Regulation Number
- 872.3070
- Review Panel
- DE
- Submission Type