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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K153359
Device Name BardPort®, SlimPort®, and X-Port® Implanted Ports
Applicant
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact JAMES R. DAVIS
Correspondent
C.R. Bard, Inc.
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Correspondent Contact JAMES R. DAVIS
Regulation Number880.5965
Classification Product Code
LJT  
Date Received11/20/2015
Decision Date 05/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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