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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 K902394
Device Name RESUBMITTED MULTIORGAN PERFUSION CANNULA
Original Applicant
FRESENIUS USA, INC.
120 albany st.
p.o. box 2623
new brunswick,  NJ  08903
Original Contact ron guido
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/30/1990
Decision Date 09/27/1990
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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