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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 K983791
Device Name PERIPHERAL RETROGRADE CARDIAPLEGIA CANNULA
Original Applicant
EDWARDS LIFESCIENCES RESEARCH MEDICAL
6864 south 300 west
midvale,  UT  84047
Original Contact john w smith
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/27/1998
Decision Date 06/11/1999
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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