Device Classification Name |
System, Dialysate Delivery, Central Multiple Patient
|
510(k) Number |
K844756 |
Device Name |
ST FAMILY OF HOLLOW FIBER DIALYZERS |
Applicant |
TRAVENOL LABORATORIES, S.A. |
DEERFIELD,
IL
60015
|
|
Applicant Contact |
JULIA A MEYER |
Correspondent |
TRAVENOL LABORATORIES, S.A. |
DEERFIELD,
IL
60015
|
|
Correspondent Contact |
JULIA A MEYER |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 12/05/1984 |
Decision Date | 01/16/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|