Device Classification Name |
system, perfusion, kidney
|
510(k) Number |
K911587 |
Device Name |
K-SOL(TM) |
Applicant |
ALCON LABORATORIES |
6201 SOUTH FREEWAY |
R7-14 |
FORT WORTH,
TX
76134 -2099
|
|
Applicant Contact |
DENISE E MCEACHERN |
Correspondent |
ALCON LABORATORIES |
6201 SOUTH FREEWAY |
R7-14 |
FORT WORTH,
TX
76134 -2099
|
|
Correspondent Contact |
DENISE E MCEACHERN |
Regulation Number | 876.5880
|
Classification Product Code |
|
Date Received | 04/09/1991 |
Decision Date | 11/01/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|