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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 K061628
Device Name JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
Applicant
Maquet Cardiopulmonary, AG
414 Maryjoe Way
Warrington,  PA  18976
Applicant Contact JAMES COLLIE
Correspondent
Maquet Cardiopulmonary, AG
414 Maryjoe Way
Warrington,  PA  18976
Correspondent Contact JAMES COLLIE
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received06/12/2006
Decision Date 08/22/2006
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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