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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 K063481
Device Name MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
Applicant
ABBOTT VASCULAR INC.
3200 Lakeside Drive
Santa Clara,  CA  95054
Applicant Contact NADINE SMITH
Correspondent
ABBOTT VASCULAR INC.
3200 Lakeside Drive
Santa Clara,  CA  95054
Correspondent Contact NADINE SMITH
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/17/2006
Decision Date 09/14/2007
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
Predetermined Change
Control Plan Authorized		 No
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