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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 K022730
Device Name PERFADEX SOLUTION FOR LUNG PRESERVATION
Applicant
Vitrolife AB
155 Cider Mill Rd.
Ringoes,  NJ  08551
Applicant Contact KARL A POSSELT
Correspondent
Vitrolife AB
155 Cider Mill Rd.
Ringoes,  NJ  08551
Correspondent Contact KARL A POSSELT
Regulation Number876.5880
Classification Product Code
MSB  
Date Received08/16/2002
Decision Date 10/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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