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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 K081184
Device Name GORE VIABIL BILILARY ENDOPROSTHESIS
Applicant
W.L. Gore & Associates, Inc. Medical Products Div.
3250 W. Kiltie Ln.
Flagstaff,  AZ  86002 -0500
Applicant Contact Michael Ivey
Correspondent
W.L. Gore & Associates, Inc. Medical Products Div.
3250 W. Kiltie Ln.
Flagstaff,  AZ  86002 -0500
Correspondent Contact Michael Ivey
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/25/2008
Decision Date 07/22/2008
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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