510(k) K991004
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1999
- Date Received
- March 25, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lock, Wire, And Ligature, Intraoral
- Device Class
- Class II
- Regulation Number
- 872.4600
- Review Panel
- DE
- Submission Type