Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes— 510(k) K192908

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K192908 for Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes, Substantially Equivalent on 2019-11-14. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.

Clearance details

Applicant
Wilson-Cook Medical, Inc.
Product code
Code FDX
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Winston-Salem, NC, US
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