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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, Non-Implanted
510(k) Number K153190
Device Name Zenysis Short-Term Dialysis Catheter
Applicant
C.R BARD INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Applicant Contact SILVIA DE LA BARRA
Correspondent
C.R BARD INC.
605 NORTH 5600 WEST
SALT LAKE CITY,  UT  84116
Correspondent Contact SILVIA DE LA BARRA
Regulation Number876.5540
Classification Product Code
MPB  
Date Received11/03/2015
Decision Date 01/05/2016
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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