Clearance Summary
INFA COMPLETE BREAST PUMP & MILK STORAG received FDA 510(k) clearance under submission number K840325, sponsored by Monterey Laboratories, 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 1984-03-05.
- Submission: K840325
- Applicant / Sponsor: Monterey Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5150
- Decision date: 1984-03-05
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.