510(k) K925088
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 1993
- Date Received
- October 7, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retainer, Screw Expansion, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5410
- Review Panel
- DE
- Submission Type