Clearance Summary
KANESON/COMFORT PLUS MANUAL BREAST PUMP received FDA 510(k) clearance under submission number K813247, sponsored by Marshall Electronics, 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 1981-12-03.
- Submission: K813247
- Applicant / Sponsor: Marshall Electronics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5150
- Decision date: 1981-12-03
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.