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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 K000881
FOIA Releasable 510(k) K000881
Device Name PERFADEX SOLUTION FOR ORGAN PRESERVATION
Applicant
Vitrolife Sweden AB
155 Cider Mill Rd.
Ringoes,  NJ  08551
Applicant Contact KARL A POSSELT
Correspondent
Vitrolife Sweden AB
155 Cider Mill Rd.
Ringoes,  NJ  08551
Correspondent Contact KARL A POSSELT
Regulation Number876.5880
Classification Product Code
MSB  
Date Received03/20/2000
Decision Date 03/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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