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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reservoir, Blood, Cardiopulmonary Bypass
510(k) Number K022281
Device Name SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
Applicant
Polystan A/S
Walgerholm 8
Vaerlose,  DK DK-3500
Applicant Contact DANA OLSEN
Correspondent
Polystan A/S
Walgerholm 8
Vaerlose,  DK DK-3500
Correspondent Contact DANA OLSEN
Regulation Number870.4400
Classification Product Code
DTN  
Date Received07/15/2002
Decision Date 08/06/2002
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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