Clearance Summary
AXIPUMP MANUAL BREAST PUMP received FDA 510(k) clearance under submission number K823461, sponsored by D.J. Colgate Medical, Ltd.. 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 1983-01-18.
- Submission: K823461
- Applicant / Sponsor: D.J. Colgate Medical, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5150
- Decision date: 1983-01-18
Classification & Regulation
This clearance is catalogued under FDA product code HGY and 21 CFR 884.5150, within the Obstetrics/Gynecology review panel as a Class I device.