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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 K022391
Device Name MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
Applicant
ORGAN RECOVERY SYSTEMS, INC.
701 EAST BAY ST.
SUITE 433
CHARLESTON,  SC  29466
Applicant Contact STANLEY HARRIS
Correspondent
ORGAN RECOVERY SYSTEMS, INC.
701 EAST BAY ST.
SUITE 433
CHARLESTON,  SC  29466
Correspondent Contact STANLEY HARRIS
Regulation Number876.5880
Classification Product Code
KDN  
Date Received07/23/2002
Decision Date 10/21/2002
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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