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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 K103478
Device Name SINGLE USE BILIARY DRAINAGE STENT V
Applicant
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Applicant Contact STACY ABBATIELLO KLUESNER
Correspondent
Olympus Medical Systems Corporation
3500 Corporate Pkwy., P.O. Box 610
Center Valley,  PA  18034 -0610
Correspondent Contact STACY ABBATIELLO KLUESNER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/26/2010
Decision Date 02/24/2011
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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