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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 K181446
Device Name Bard Power-Injectable Implantable Ports (PowerPorts®)
Applicant
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Jeff Peterson
Correspondent
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Jeff Peterson
Regulation Number880.5965
Classification Product Code
LJT  
Date Received06/01/2018
Decision Date 07/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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