510(k) K891186
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 1989
- Date Received
- March 6, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Aligner, Beam, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1820
- Review Panel
- DE
- Submission Type