Clearance Summary
HASSON BUEC-3 received FDA 510(k) clearance under submission number K820672, sponsored by Bivona Medical Technologies. 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 1982-07-30.
- Submission: K820672
- Applicant / Sponsor: Bivona Medical Technologies
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1982-07-30
Classification & Regulation
This clearance is catalogued under FDA product code HDP and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.