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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 K143609
Device Name Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
Applicant
Olympus Surgical Technologies America
136 Turnpike Rd.
Southborough,  MA  01772 -2104
Applicant Contact MARY ANNE PATELLA
Correspondent
Olympus Surgical Technologies America
136 Turnpike Rd.
Southborough,  MA  01772 -2104
Correspondent Contact MARY ANNE PATELLA
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
KNQ  
Date Received12/19/2014
Decision Date 03/27/2015
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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