Clearance Summary
MULTI-UNIT, MULTI-PURPOSE DEVICE received FDA 510(k) clearance under submission number K813638, sponsored by The Scott & Fetzer Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1982-05-07.
- Submission: K813638
- Applicant / Sponsor: The Scott & Fetzer Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6510
- Decision date: 1982-05-07
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.