Clearance Summary
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 received FDA 510(k) clearance under submission number K980356, sponsored by Canadian Medical Brush, 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 1998-04-16.
- Submission: K980356
- Applicant / Sponsor: Canadian Medical Brush, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1998-04-16
Classification & Regulation
This clearance is catalogued under FDA product code HHT and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.