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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K012774
Device Name JOSTRA ARTERIAL PERFUSION CANNULAE
Original Applicant
JOSTRA AG
478 media rd.
oxford,  PA  19363
Original Contact kathleen johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/20/2001
Decision Date 11/16/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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