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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 K841402
Device Name TEMPERATURE CONTROL & MONITOR
Applicant
SAMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SAMS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number870.4250
Classification Product Code
DWC  
Date Received04/03/1984
Decision Date 06/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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