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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K170740
Device Name GORE VIABIL Short Wire Biliary Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21921
Applicant Contact Barbara L. Smith
Correspondent
W. L. Gore & Associates, Inc.
301 Airport Rd.
Elkton,  MD  21921
Correspondent Contact Barbara L. Smith
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/10/2017
Decision Date 05/08/2017
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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