Device Classification Name |
system, perfusion, kidney
|
510(k) Number |
K022391 |
Device Name |
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION |
Applicant |
ORGAN RECOVERY SYSTEMS, INC. |
701 EAST BAY ST. |
SUITE 433 |
charleston,
SC
29466
|
|
Applicant Contact |
stanley harris |
Correspondent |
ORGAN RECOVERY SYSTEMS, INC. |
701 EAST BAY ST. |
SUITE 433 |
charleston,
SC
29466
|
|
Correspondent Contact |
stanley harris |
Regulation Number | 876.5880
|
Classification Product Code |
|
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
|
|
|