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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, perfusion, kidney, disposable
510(k) Number K900492
Device Name LABELING CHANGE - VIASPAN(TM) (BELZER UW)
Applicant
THE DU PONT CO.
CHESTNUT RUN PLAZA
P.O. BOX 80715
WILMINGTON,  DE 
Applicant Contact ANN M GRUMET
Correspondent
THE DU PONT CO.
CHESTNUT RUN PLAZA
P.O. BOX 80715
WILMINGTON,  DE 
Correspondent Contact ANN M GRUMET
Regulation Number876.5880
Classification Product Code
KDL  
Date Received02/02/1990
Decision Date 03/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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