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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 K081311
Device Name POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER
Original Applicant
C.R. BARD, INC.
605 north 5600 west
salt lake city,  UT  84116
Original Contact jihyun kim
Regulation Number880.5965
Classification Product Code
LJT  
Date Received05/09/2008
Decision Date 06/04/2008
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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