MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION

System, Perfusion, Kidney

ORGAN RECOVERY SYSTEMS, INC.

The following data is part of a premarket notification filed by Organ Recovery Systems, Inc. with the FDA for Modification To Kps-1, Kidney Perfusion Solutiion.

Pre-market Notification Details

Device IDK022391
510k NumberK022391
Device Name:MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
ClassificationSystem, Perfusion, Kidney
Applicant ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston,  SC  29466
ContactStanley Harris
CorrespondentStanley Harris
ORGAN RECOVERY SYSTEMS, INC. 701 EAST BAY ST. SUITE 433 Charleston,  SC  29466
Product CodeKDN  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-23
Decision Date2002-10-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10815045020343 K022391 000

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