510(k) K792106
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1979
- Date Received
- October 25, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Appliance, Facial Fracture, External
- Device Class
- Class I
- Regulation Number
- 878.3250
- Review Panel
- SU
- Submission Type