Clearance Summary
MALE URINAL received FDA 510(k) clearance under submission number K771738, sponsored by Bemis Health Care. 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 1977-09-28.
- Submission: K771738
- Applicant / Sponsor: Bemis Health Care
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6730
- Decision date: 1977-09-28
Classification & Regulation
This clearance is catalogued under FDA product code FNP and 21 CFR 880.6730, within the General Hospital review panel as a Class I device.