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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Hemodialysis, Implanted
510(k) Number K171571
Device Name NexSite HD, Hemodialysis Step Tip Catheter (60cm)
Applicant
Marvao Medical Devices, Ltd.
GMIT Innovation in Business Centre, Dublin Road
Galway,  IE
Applicant Contact Christopher Davey
Correspondent
Boston Biomedical Associates
100 Crowley Drive
Suite 216
Marlborough,  MA  01752
Correspondent Contact Mary P LeGraw
Regulation Number876.5540
Classification Product Code
MSD  
Date Received05/30/2017
Decision Date 11/30/2017
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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