Clearance Summary
SINGLE HANDED BREAST PUMP received FDA 510(k) clearance under submission number K941112, sponsored by Macneil Baby Care , 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 1995-01-30.
- Submission: K941112
- Applicant / Sponsor: Macneil Baby Care , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 1995-01-30
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.