MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION


Device Classification Name

system, perfusion, kidney

510(k) Number K022391
Device Name MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
Original Applicant
ORGAN RECOVERY SYSTEMS, INC.
701 east bay st.
suite 433
charleston, 
SC 
29466

Original Contact stanley harris
Regulation Number 876.5880
Classification Product Code
KDN  
Date Received 07/23/2002
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