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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 K013393
Device Name HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
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 Received10/15/2001
Decision Date 11/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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