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 Number | 876.5880
|
Classification Product Code |
|
Date Received | 10/29/2001 |
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
|
|
|