Clearance Summary
MODEL 1750 STANDING URINAL received FDA 510(k) clearance under submission number K790663, sponsored by Life-Tech Instruments, Inc.. 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 1979-04-24.
- Submission: K790663
- Applicant / Sponsor: Life-Tech Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1800
- Decision date: 1979-04-24
Classification & Regulation
This clearance is catalogued under FDA product code FFG and 21 CFR 876.1800, within the Gastroenterology, Urology review panel as a Class II device.