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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 K031331
Device Name WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
Applicant
ABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City,  CA  94063
Applicant Contact JOANNA KUSKOWSKI
Correspondent
ABBOTT VASCULAR INC.
400 Saginaw Drive
Redwood City,  CA  94063
Correspondent Contact JOANNA KUSKOWSKI
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/28/2003
Decision Date 08/12/2003
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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