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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 K132829
Device Name QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
Applicant
MAQUET CARDIOPULMONARY AG
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Applicant Contact WHITNEY TORNING
Correspondent
MAQUET CARDIOPULMONARY AG
45 BARBOUR POND DRIVE
WAYNE,  NJ  07470
Correspondent Contact WHITNEY TORNING
Regulation Number870.4350
Classification Product Code
DTZ  
Subsequent Product Codes
DTM   DTR  
Date Received09/09/2013
Decision Date 10/08/2013
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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