Clearance Summary
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT received FDA 510(k) clearance under submission number K013226, sponsored by Evenflo Company, 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 2001-12-20.
- Submission: K013226
- Applicant / Sponsor: Evenflo Company, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5150
- Decision date: 2001-12-20
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.