510(k) K952218
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1995
- Date Received
- May 11, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Jaw Tracking, For Monitoring Jaw Positions
- Device Class
- Class I
- Regulation Number
- 872.2060
- Review Panel
- DE
- Submission Type