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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system and accessories, isolated heart, transport and preservation
510(k) Number K081997
Device Name PERFADEX WITH THAM
Applicant
VITROLIFE SWEDEN AB
FAKTORVAGEN 13
KUNGSBACKA,  SE SE-434 37
Applicant Contact KJELL KJORK
Correspondent
VITROLIFE SWEDEN AB
FAKTORVAGEN 13
KUNGSBACKA,  SE SE-434 37
Correspondent Contact KJELL KJORK
Regulation Number876.5880
Classification Product Code
MSB  
Date Received07/14/2008
Decision Date 10/09/2008
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
Recalls CDRH Recalls
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