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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 K150487
Device Name X-Suit NIR Biliary Metallic Stent
Applicant
Medinol , Ltd.
Kiryat Atidim, Bldg. 8
Tel Aviv,  IL 6158101
Applicant Contact Michal Hershkovitz
Correspondent
CardioMed Device Consultants, LLC
5523 Research Park Dr., Suite 360
Baltimore,  MD  21228
Correspondent Contact H. Semih Oktay
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/25/2015
Decision Date 02/12/2016
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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