Clearance Summary
DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555 received FDA 510(k) clearance under submission number K904850, sponsored by Micro Motors, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1991-01-25.
- Submission: K904850
- Applicant / Sponsor: Micro Motors, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1991-01-25
Classification & Regulation
This clearance is catalogued under FDA product code EFS and 21 CFR 872.6510, within the Dental review panel as a Class I device.