Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes

Endoscopic Cytology Brush

Wilson-Cook Medical, Inc

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc with the FDA for Fusion Cytology Brush, Cytomax Ii Double Lumen Cytology Brushes.

Pre-market Notification Details

Device IDK192908
501k NumberK192908
Device Name:Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes
ClassificationEndoscopic Cytology Brush
Applicant Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem,  NC  27105
ContactTiffanny A. Thomas
CorrespondentTiffanny A. Thomas
Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem,  NC  27105
Product CodeFDX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-15
Decision Date2019-11-14

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