Clearance Summary
MEBBY GENTLEFEED DUO BREAST PUMP/DUAL EXPRESSER PUMP received FDA 510(k) clearance under submission number K081463, sponsored by Medel S.P.A.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2009-02-06.
- Submission: K081463
- Applicant / Sponsor: Medel S.P.A.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 2009-02-06
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.