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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name endoscopic cytology brush
510(k) Number K181317
Device Name Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
Applicant
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem,  NC  27105
Applicant Contact Sierra Lowe
Correspondent
Wilson-Cook Medical, Inc.
4900 Bethania Station Road
Winston-Salem,  NC  27105
Correspondent Contact Sierra Lowe
Regulation Number876.1500
Classification Product Code
FDX  
Date Received05/18/2018
Decision Date 02/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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