Device Classification Name |
Set, Perfusion, Kidney, Disposable
|
510(k) Number |
K043461 |
Device Name |
CUSTODIOL |
Applicant |
DR. FRANZ KOHLER CHEMIE GMBH |
2305 GOLD MINE RD. |
BROOKEVILLE,
MD
20833
|
|
Applicant Contact |
T. WHIT ATHEY |
Correspondent |
DR. FRANZ KOHLER CHEMIE GMBH |
2305 GOLD MINE RD. |
BROOKEVILLE,
MD
20833
|
|
Correspondent Contact |
T. WHIT ATHEY |
Regulation Number | 876.5880
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/15/2004 |
Decision Date | 02/28/2005 |
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
|
|
|