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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 K083627
Device Name WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Marybeth Gamber
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Marybeth Gamber
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/08/2008
Decision Date 04/07/2009
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Clinical Trials NCT00433771
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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