Device Classification Name |
System, Dialysate Delivery, Central Multiple Patient
|
510(k) Number |
K860296 |
Device Name |
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES |
Applicant |
PHYSICIANS SURGEONS PURCHASING GROUP |
8927 SOUTH VERMONT AVE. |
LOS ANGELES,
CA
90044
|
|
Applicant Contact |
MACK MACDONALD |
Correspondent |
PHYSICIANS SURGEONS PURCHASING GROUP |
8927 SOUTH VERMONT AVE. |
LOS ANGELES,
CA
90044
|
|
Correspondent Contact |
MACK MACDONALD |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 01/28/1986 |
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
|
|
|