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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 K093522
Device Name QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
Applicant
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Applicant Contact FRANK MOEHRKE
Correspondent
Maquet Cardiopulmonary, AG
Hechinger Strasse 38
Hirrlingen,  DE 72145
Correspondent Contact FRANK MOEHRKE
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTR  
Date Received11/13/2009
Decision Date 12/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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