Clearance Summary
EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 received FDA 510(k) clearance under submission number K032845, sponsored by The First Years, 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 2004-04-05.
- Submission: K032845
- Applicant / Sponsor: The First Years, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5150
- Decision date: 2004-04-05
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.