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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 K050501
Device Name MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
Applicant
ABBOTT VASCULAR DEVICES
400 SAGINAW DR.
REDWOOD CITY,  CA  94063
Applicant Contact ANN E LEONARD
Correspondent
ABBOTT VASCULAR DEVICES
400 SAGINAW DR.
REDWOOD CITY,  CA  94063
Correspondent Contact ANN E LEONARD
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/28/2005
Decision Date 03/14/2005
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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