Clearance Summary
DRYTIME FOR BLADDER CONTROL SILENT received FDA 510(k) clearance under submission number K962416, sponsored by Bio-Systems Research. 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 1996-07-22.
- Submission: K962416
- Applicant / Sponsor: Bio-Systems Research
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.2040
- Decision date: 1996-07-22
Classification & Regulation
This clearance is catalogued under FDA product code KPN and 21 CFR 876.2040, within the Gastroenterology, Urology review panel as a Class II device.