510(k) K971818
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1997
- Date Received
- May 16, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Jaw Repositioning
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type