Clearance Summary
1500 ML DISPOSABLE ENEMA CONTAINER(1110) received FDA 510(k) clearance under submission number K800960, sponsored by The Healthcare Group Laboratories, 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 1980-05-14.
- Submission: K800960
- Applicant / Sponsor: The Healthcare Group Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5210
- Decision date: 1980-05-14
Classification & Regulation
This clearance is catalogued under FDA product code FCE and 21 CFR 876.5210, within the Gastroenterology, Urology review panel as a Class I device.