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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 K020529
Device Name LARGE CENTRIFUGAL BLOOD PUMP, MODEL CP-2
Applicant
A-Med Systems, Inc.
2491 Boatman Ave.
West Sacramento,  CA  95691
Applicant Contact CYNTHIA G ROYSTER
Correspondent
A-Med Systems, Inc.
2491 Boatman Ave.
West Sacramento,  CA  95691
Correspondent Contact CYNTHIA G ROYSTER
Regulation Number870.4360
Classification Product Code
KFM  
Date Received02/19/2002
Decision Date 08/26/2002
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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