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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 K110104
Device Name BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT 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 Number870.5900
Classification Product Code
DWJ  
Date Received01/13/2011
Decision Date 02/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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