Clearance Summary
FEMALE EXTERNAL URINARY APPLIANCE received FDA 510(k) clearance under submission number K823450, sponsored by Diamed Division Ill. Tool Works, 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 1982-12-28.
- Submission: K823450
- Applicant / Sponsor: Diamed Division Ill. Tool Works, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5250
- Decision date: 1982-12-28
Classification & Regulation
This clearance is catalogued under FDA product code KNX and 21 CFR 876.5250, within the Gastroenterology, Urology review panel as a Class II device.