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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 K113582
Device Name ARCHSTENT BILIARY SYSTEM
Applicant
Ostial Corporation
510 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact KAITLIN VON HOFFMANN
Correspondent
Ostial Corporation
510 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact KAITLIN VON HOFFMANN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/05/2011
Decision Date 06/29/2012
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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