Clearance Summary
VAGINAL SPECULUM - DISPOSABLE received FDA 510(k) clearance under submission number K841909, 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 1984-07-31.
- Submission: K841909
- Applicant / Sponsor: Galenica Enterprises, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1984-07-31
Classification & Regulation
This clearance is catalogued under FDA product code HIB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.