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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, thermal regulating
510(k) Number K121669
Model 542
Device Name WARMAIR MODEL 135 HYPERTHERMIA SYSTEM (CONTROLLER AND BLANKETS)
Original Applicant
CINCINNATI SUB-ZERO PRODUCTS, INC.
12011 mosteller rd.
cincinnati,  OH  45241
Original Contact steven j berke
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/06/2012
Decision Date 07/03/2012
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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