Clearance Summary
EGNELL-LACT B BATTERY-OPERATED BREAST PUMP received FDA 510(k) clearance under submission number K844307, sponsored by Egnell, 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 1985-02-04.
- Submission: K844307
- Applicant / Sponsor: Egnell, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 1985-02-04
Classification & Regulation
This clearance is catalogued under FDA product code HGX and 21 CFR 884.5160, within the Obstetrics/Gynecology review panel as a Class II device.