Clearance Summary
DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF received FDA 510(k) clearance under submission number K872006, sponsored by Mac Lee Medical Products. 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 1987-11-17.
- Submission: K872006
- Applicant / Sponsor: Mac Lee Medical Products
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1987-11-17
Classification & Regulation
This clearance is catalogued under FDA product code FGD and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.