Clearance Summary
LEG URINAL received FDA 510(k) clearance under submission number K913155, sponsored by Ezmt Valve Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1991-09-16.
- Submission: K913155
- Applicant / Sponsor: Ezmt Valve Co., Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4495
- Decision date: 1991-09-16
Classification & Regulation
This clearance is catalogued under FDA product code GAQ and 21 CFR 878.4495, within the General, Plastic Surgery review panel as a Class II device.