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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gauge, pressure, coronary, cardiopulmonary bypass
510(k) Number K113235
Model 66000,61006,62000,62006,61000LK,61006LK,62000LK,620061LK
Device Name PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
Original Applicant
MEDTRONIC INC.
8200 coral sea street ne
mounds view,  MN  55112
Original Contact amra racic
Regulation Number870.4310
Classification Product Code
DXS  
Date Received11/02/2011
Decision Date 12/02/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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