Clearance Summary
DISPOSABLE AMNIOTOME received FDA 510(k) clearance under submission number K883283, sponsored by Galenica Enterprises, 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 1988-10-18.
- Submission: K883283
- Applicant / Sponsor: Galenica Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 1988-10-18
Classification & Regulation
This clearance is catalogued under FDA product code HGG and 21 CFR 884.5070, within the Obstetrics/Gynecology review panel as a Class II device.