510(k) K130130
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 2013
- Date Received
- January 17, 2013
- 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