Clearance Summary
REGULATORS, HIGH SUCTION received FDA 510(k) clearance under submission number K760317, sponsored by Harris-Lake, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1976-08-04.
- Submission: K760317
- Applicant / Sponsor: Harris-Lake, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1976-08-04
Classification & Regulation
This clearance is catalogued under FDA product code KDP and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.