510(k) K770359
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1977
- Date Received
- February 22, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, External Aesthetic Restoration, Used With Adhesive
- Device Class
- Class I
- Regulation Number
- 878.3800
- Review Panel
- SU
- Submission Type