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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 K072549
Device Name TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
Original Applicant
C.R. BARD, INC.
605 n 5600 w
salt lake city,  UT  84116
Original Contact susan d scott
Regulation Number880.5965
Classification Product Code
LJT  
Date Received09/10/2007
Decision Date 11/14/2007
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
Recalls CDRH Recalls
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