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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, biopsy, suction
510(k) Number K153763
Device Name Howell Biliary Aspiration Needle
Applicant
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION ROAD
WINSTON SALEM,  NC  27105
Applicant Contact Jennifer McMahan
Correspondent
WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION ROAD
WINSTON SALEM,  NC  27105
Correspondent Contact Ashley Howard
Regulation Number876.1075
Classification Product Code
FCK  
Date Received12/30/2015
Decision Date 04/06/2017
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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