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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 K810647
Device Name SHILEY OXYGENATOR THERMISTOR PROBE
Applicant
Shiley, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Shiley, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number870.4250
Classification Product Code
DWC  
Date Received03/11/1981
Decision Date 04/03/1981
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
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