Clearance Summary
SUCTION DEVICE-PHARYNEAL DEVICE received FDA 510(k) clearance under submission number K840669, sponsored by Lipsky-Dale Medical Products. 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 1984-06-11.
- Submission: K840669
- Applicant / Sponsor: Lipsky-Dale Medical Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6740
- Decision date: 1984-06-11
Classification & Regulation
This clearance is catalogued under FDA product code JOL and 21 CFR 880.6740, within the General Hospital review panel as a Class II device.