Clearance Summary
FRANK MILK PUMP received FDA 510(k) clearance under submission number K895114, sponsored by Buttner-Frank GmbH. 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 1990-03-05.
- Submission: K895114
- Applicant / Sponsor: Buttner-Frank GmbH
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5160
- Decision date: 1990-03-05
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.