Clearance Summary
MEDELA BREAST-PUMP LACTINA received FDA 510(k) clearance under submission number K875300, sponsored by Medela, 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 1988-04-06.
- Submission: K875300
- Applicant / Sponsor: Medela, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 1988-04-06
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.