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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 K090512
Device Name POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER
Original Applicant
C.R. BARD, INC.
605 north 5600 west
salt lake city,  UT  84116
Original Contact angela m brady
Regulation Number880.5965
Classification Product Code
LJT  
Date Received02/26/2009
Decision Date 03/27/2009
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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