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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 K122899
Device Name POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
Original Applicant
C.R. BARD, INC.
605 north 5600 west
salt lake city,  UT  84116
Original Contact amy honey
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/21/2012
Decision Date 11/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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