Clearance Summary
GENTLE FLOW BREAST PUMP received FDA 510(k) clearance under submission number K833835, sponsored by Eklund & 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 1983-11-28.
- Submission: K833835
- Applicant / Sponsor: Eklund & Co.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5150
- Decision date: 1983-11-28
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.