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510(k) K192908

Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes by Wilson-Cook Medical, Inc. — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2019
Date Received
October 15, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

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