510(k) K854765
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 1986
- Date Received
- November 27, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clasp, Preformed
- Device Class
- Class I
- Regulation Number
- 872.3285
- Review Panel
- DE
- Submission Type