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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 K101589
Device Name BLANKETROL III, MODEL 233 AND COOLBLUE, MODEL 25-01 HYPER-HYPOTHERMIA SYSTEMS
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 Received06/07/2010
Decision Date 09/20/2010
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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