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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 K883603
Device Name SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
Applicant
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Applicant Contact D SHIMOKOCHI
Correspondent
3M Health Care, Sarns
6200 Jackson Rd.
Ann Arbor,  MI  48103
Correspondent Contact D SHIMOKOCHI
Regulation Number870.4250
Classification Product Code
DWC  
Date Received08/23/1988
Decision Date 11/03/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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