Clearance Summary
FOLEY-TEMP received FDA 510(k) clearance under submission number K831567, sponsored by Mallinckrodt Critical Care. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1983-08-10.
- Submission: K831567
- Applicant / Sponsor: Mallinckrodt Critical Care
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 1983-08-10
Classification & Regulation
This clearance is catalogued under FDA product code KOD and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.