Clearance Summary
4 SURE URINARY LEG BAG received FDA 510(k) clearance under submission number K896728, sponsored by The Boston & Pacific Co., 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 1990-02-20.
- Submission: K896728
- Applicant / Sponsor: The Boston & Pacific Co., Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5250
- Decision date: 1990-02-20
Classification & Regulation
This clearance is catalogued under FDA product code FAQ and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class I device.