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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 K081956
Device Name MEDINOL X-SUIT NIR BILIARY METALLIC STENT
Applicant
MEDINOL LTD.
386 WEST MAIN STREET
SUITE 7
NORTHBORO,  MA  01532
Applicant Contact LEO L BASTA
Correspondent
MEDINOL LTD.
386 WEST MAIN STREET
SUITE 7
NORTHBORO,  MA  01532
Correspondent Contact LEO L BASTA
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/09/2008
Decision Date 01/09/2009
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
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