Clearance Summary
IRRIGATOR STAND received FDA 510(k) clearance under submission number K894891, sponsored by Commercial Products & Engineering Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1989-08-23.
- Submission: K894891
- Applicant / Sponsor: Commercial Products & Engineering Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1989-08-23
Classification & Regulation
This clearance is catalogued under FDA product code HDC and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.