510(k) K821521
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1982
- Date Received
- May 21, 1982
- 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