Clearance Summary
CENTURION VAGINAL SPECULUM received FDA 510(k) clearance under submission number K897100, sponsored by Tri-State Hospital Supply 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 1990-03-16.
- Submission: K897100
- Applicant / Sponsor: Tri-State Hospital Supply Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1990-03-16
Classification & Regulation
This clearance is catalogued under FDA product code HIC and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.