Device Classification Name |
dialyzer, high permeability with or without sealed dialysate system
|
510(k) Number |
K861776 |
Device Name |
HIGH EFFICIENCY HEMODIALYSIS SYSTEM |
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 | 876.5860
|
Classification Product Code |
|
Date Received | 05/08/1986 |
Decision Date | 06/19/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|