Clearance Summary
VAN JON SUPER CLYSTER(KIT, ENEMA received FDA 510(k) clearance under submission number K843792, sponsored by Van Jon Co.. 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 1985-04-22.
- Submission: K843792
- Applicant / Sponsor: Van Jon Co.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5210
- Decision date: 1985-04-22
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.