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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 K004001
Device Name MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR
Applicant
DIDECO
14401 W. 65th Way
Arvada,  CO  80004 -3599
Applicant Contact BARBARA WATSON
Correspondent
DIDECO
14401 W. 65th Way
Arvada,  CO  80004 -3599
Correspondent Contact BARBARA WATSON
Regulation Number870.4350
Classification Product Code
DTZ  
Date Received12/26/2000
Decision Date 10/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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