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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 K973171
Device Name NIR BILIARY STENT
Applicant
Medinol, Ltd.
Kiryat Atidim, Bldg. 7
Entrance A, 5th Floor , Pob 58165
Tel-Aviv,  IL 61581
Applicant Contact TAMI ABUDI
Correspondent
Medinol, Ltd.
Kiryat Atidim, Bldg. 7
Entrance A, 5th Floor , Pob 58165
Tel-Aviv,  IL 61581
Correspondent Contact TAMI ABUDI
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/25/1997
Decision Date 11/13/1998
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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