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510(k) K171573

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2017
Date Received
May 30, 2017
Clearance Type
Traditional
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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