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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 K991170
Device Name RETROGRADE CARDIOPLEGIA CANNULA WITH DURAFLO TREATMENT, MODEL DII-RC-014
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 Received04/07/1999
Decision Date 07/02/1999
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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