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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 K090511
Device Name QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
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  
Date Received02/26/2009
Decision Date 06/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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