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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 K180868
Device Name Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
Applicant
Cook Ireland
O' Halloran Rd., National Technology Park
Limerick,  IE
Applicant Contact Jacinta Kilmartin
Correspondent
Cook Ireland
O' Halloran Rd., National Technology Park
Limerick,  IE
Correspondent Contact Jacinta Kilmartin
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/03/2018
Decision Date 07/06/2018
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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