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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 K014205
Device Name MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
Applicant
MEDTRONIC AVE, INC.
2170-A NORTHPOINT PRKWY
SANTA ROSA,  CA  95407
Applicant Contact KEVIN DRISCO
Correspondent
MEDTRONIC AVE, INC.
2170-A NORTHPOINT PRKWY
SANTA ROSA,  CA  95407
Correspondent Contact KEVIN DRISCO
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/21/2001
Decision Date 01/14/2002
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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