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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name controller, temperature, cardiopulmonary bypass
510(K) Number K122813
Model 400CE
Device Name HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
Applicant
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 mosteller rd.
cincinnati,  OH  45241
Contact steven j berke
Regulation Number870.4250
Classification Product Code
DWC  
Date Received09/13/2012
Decision Date 12/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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