510(k) K955528
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 1996
- Date Received
- December 4, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Headgear, Extraoral, Orthodontic
- Device Class
- Class II
- Regulation Number
- 872.5500
- Review Panel
- DE
- Submission Type