Clearance Summary
BARZELL-WHITMORE MAROON BELLS, INC. COLO-RECTAL MOVER, MODEL 3900 received FDA 510(k) clearance under submission number K000960, sponsored by Barzell-Whitmore Maroon Bells, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-05-26.
- Submission: K000960
- Applicant / Sponsor: Barzell-Whitmore Maroon Bells, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2000-05-26
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.