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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
Device Name HEMOTHERM MODEL 400CE COOLER/HEATER SYSTEM
Applicant
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 MOSTELLER RD.
CINCINNATI,  OH  45241
Applicant Contact STEVEN J BERKE
Correspondent
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 MOSTELLER RD.
CINCINNATI,  OH  45241
Correspondent Contact STEVEN J BERKE
Regulation Number870.4250
Classification Product Code
DWC  
Date Received09/13/2012
Decision Date 12/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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