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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 K041962
Device Name XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
Applicant
Abbott Laboratories
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact JOANNA KUSKOWSKI
Correspondent
Abbott Laboratories
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact JOANNA KUSKOWSKI
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/21/2004
Decision Date 10/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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