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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 K013575
Device Name KPS-I, THE KIDNEY PERFUSION SOLUTION
Applicant
ORGAN RECOVERY SYSTEMS, INC.
701 EAST BAY ST.
SUITE 433
charleston,  SC  29403
Applicant Contact stanley j harris
Correspondent
ORGAN RECOVERY SYSTEMS, INC.
701 EAST BAY ST.
SUITE 433
charleston,  SC  29403
Correspondent Contact stanley j harris
Regulation Number876.5880
Classification Product Code
KDN  
Date Received10/29/2001
Decision Date 01/25/2002
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
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