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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 K141363
Device Name CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
Applicant
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Applicant Contact SUSAN CHRISTENSEN
Correspondent
Merit Medical Systems, Inc.
1600 W. Merit Pkwy.
South Jordan,  UT  84095
Correspondent Contact SUSAN CHRISTENSEN
Regulation Number876.5540
Classification Product Code
MSD  
Date Received05/23/2014
Decision Date 06/18/2014
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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