Clearance Summary
HUI MINI-FLEX received FDA 510(k) clearance under submission number K895659, sponsored by Unimar, 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 1989-12-19.
- Submission: K895659
- Applicant / Sponsor: Unimar, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1700
- Decision date: 1989-12-19
Classification & Regulation
This clearance is catalogued under FDA product code HIG and 21 CFR 884.1700, within the Obstetrics/Gynecology review panel as a Class II device.