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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
510(k) Number K023132
Device Name JOSTRA MECC SYSTEM
Applicant
Jostra AG
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381
Applicant Contact KATHLEEN JOHNSON
Correspondent
Jostra AG
2828 N. Crescent Ridge Dr.
The Woodlands,  TX  77381
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4360
Classification Product Code
KFM  
Date Received09/20/2002
Decision Date 12/17/2002
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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