510(k) K945910
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 29, 1994
- Date Received
- December 2, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alloy, Gold-Based Noble Metal
- Device Class
- Class II
- Regulation Number
- 872.3060
- Review Panel
- DE
- Submission Type