LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)


Device Classification Name

system, perfusion, kidney

510(k) Number K021362
Device Name LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR)
Original Applicant
ORGAN RECOVERY SYSTEMS, INC.
701 east bay st.
suite 433
charleston, 
SC 
29403

Original Contact stanley j harris
Regulation Number 876.5880
Classification Product Code
KDN  
Date Received 04/30/2002
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