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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oxygenator, Cardiopulmonary Bypass
510(k) Number K912082
Device Name SAFE II
Applicant
Polystan A/S
8, Walgerholm
Dk-3500 Vaerlose
Denmark,  DK
Applicant Contact MOE HAVELAND
Correspondent
Polystan A/S
8, Walgerholm
Dk-3500 Vaerlose
Denmark,  DK
Correspondent Contact MOE HAVELAND
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received05/10/1991
Decision Date 12/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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