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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, perfusion, kidney
510(k) Number K091989
Device Name PERFADEX AND PERFADEX WITH THAM
Applicant
XVIVO PERFUSION AB
BOX 9080
GOTEBORG,  SE SE-40092
Applicant Contact KJELL KJORK
Correspondent
XVIVO PERFUSION AB
BOX 9080
GOTEBORG,  SE SE-40092
Correspondent Contact KJELL KJORK
Regulation Number876.5880
Classification Product Code
KDN  
Date Received07/02/2009
Decision Date 10/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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