Clearance Summary
AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG received FDA 510(k) clearance under submission number K850344, sponsored by Midwest. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1985-03-25.
- Submission: K850344
- Applicant / Sponsor: Midwest
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1985-03-25
Classification & Regulation
This clearance is catalogued under FDA product code EGS and 21 CFR 872.4200, within the Dental review panel as a Class I device.