Clearance Summary
DOUCHE UNIT-1500 ML DISP. CONTAINER received FDA 510(k) clearance under submission number K800957, sponsored by The Healthcare Group Laboratories, Inc.. 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 1980-07-14.
- Submission: K800957
- Applicant / Sponsor: The Healthcare Group Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5900
- Decision date: 1980-07-14
Classification & Regulation
This clearance is catalogued under FDA product code HED and 21 CFR 884.5900, within the Obstetrics/Gynecology review panel as a Class I device.