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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 K073423
Device Name MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE 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 Received12/05/2007
Decision Date 12/19/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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