510(k) K780814
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1978
- Date Received
- May 18, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Maintainer, Space Preformed, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5525
- Review Panel
- DE
- Submission Type