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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, umbilical artery
510(k) Number K120304
Model PIUVC-2540
Device Name FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
Original Applicant
FOOTPRINT MEDICAL INC.
1203 camden street
san antonio,  TX  78215
Original Contact clyde baker
Regulation Number880.5200
Classification Product Code
FOS  
Date Received02/01/2012
Decision Date 03/01/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
statement statement
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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