Clearance Summary
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT received FDA 510(k) clearance under submission number K963843, 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 1997-03-31.
- Submission: K963843
- Applicant / Sponsor: Micro Motors, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 1997-03-31
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.