FDA 510(k) Application Details - K873699

Device Classification Name Controller, Temperature, Cardiopulmonary Bypass

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510(K) Number K873699
Device Name Controller, Temperature, Cardiopulmonary Bypass
Applicant SEABROOK MEDICAL SYSTEMS, INC.
673 WILMER AVE.
CINCINNATI, OH US
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Contact MARK J BUCH
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Regulation Number 870.4250

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Classification Product Code DWC
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Date Received 09/16/1987
Decision Date 12/22/1987
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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