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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 K041423
Device Name VIABIL BILIARY ENDOPROSTHESIS
Applicant
W. L. GORE & ASSOCIATES, INC.
3450 WEST KILTIE LN.
FLAGSTAFF,  AZ  86001
Applicant Contact Michael Ivey
Correspondent
W. L. GORE & ASSOCIATES, INC.
3450 WEST KILTIE LN.
FLAGSTAFF,  AZ  86001
Correspondent Contact Michael Ivey
Regulation Number876.5010
Classification Product Code
FGE  
Date Received05/28/2004
Decision Date 07/21/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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