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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 K032929
Device Name MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
Applicant
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact JOANNA KUSKOWSKI
Correspondent
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact JOANNA KUSKOWSKI
Regulation Number876.5010
Classification Product Code
FGE  
Date Received09/22/2003
Decision Date 10/22/2003
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
Predetermined Change
Control Plan Authorized		 No
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