Device Classification Name |
system, dialysate delivery, central multiple patient
|
510(k) Number |
K860336 |
Device Name |
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS |
Applicant |
BREEM LABORATORIES |
8931 SOUTH VERMONT AVE. |
LOS ANGELES,
CA
90044
|
|
Applicant Contact |
JAMES STEWART |
Correspondent |
BREEM LABORATORIES |
8931 SOUTH VERMONT AVE. |
LOS ANGELES,
CA
90044
|
|
Correspondent Contact |
JAMES STEWART |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 01/29/1986 |
Decision Date | 03/04/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|