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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 K021362
FOIA Releasable 510(k) K021362
Device Name LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
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 Received04/30/2002
Decision Date 07/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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