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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K972740
Device Name HIMEX CENTRIFLOW CENTRIFUGAL PERFUSION PUMP SYSTEM (CFK01)
Applicant
Himex Production Corp.
Medical Towers Bldg
1709 Dryden, Suite 909
Houston,  TX  77030
Applicant Contact GREG GEORGES
Correspondent
Himex Production Corp.
Medical Towers Bldg
1709 Dryden, Suite 909
Houston,  TX  77030
Correspondent Contact GREG GEORGES
Regulation Number870.4360
Classification Product Code
KFM  
Date Received07/22/1997
Decision Date 02/06/1998
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
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