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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 K073693
Device Name COSTORSOL
Applicant
PRESERVATION SOLUTIONS, INC.
4250 GROVE STREET
DENVER,  CO  80211
Applicant Contact NEIL BURRIS
Correspondent
PRESERVATION SOLUTIONS, INC.
4250 GROVE STREET
DENVER,  CO  80211
Correspondent Contact NEIL BURRIS
Regulation Number876.5880
Classification Product Code
KDN  
Date Received12/31/2007
Decision Date 07/03/2008
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
Recalls CDRH Recalls
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