Clearance Summary
DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE received FDA 510(k) clearance under submission number K020726, sponsored by Dukal Corp.. 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 2002-05-15.
- Submission: K020726
- Applicant / Sponsor: Dukal Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2002-05-15
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.