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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 K060817
Device Name OMNILINK. 018 BILIARY STENT SYSTEM
Applicant
GUIDANT ENDOVASCULAR SOLUTIONS, INC.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Applicant Contact MARA CALER
Correspondent
GUIDANT ENDOVASCULAR SOLUTIONS, INC.
3200 LAKESIDE DR.
SANTA CLARA,  CA  95054
Correspondent Contact MARA CALER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/27/2006
Decision Date 06/15/2006
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
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