Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K870979 |
Device Name |
HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS |
Applicant |
INVENTORY SUPPLY CORP. |
1633 E. LINCOLN AVE. |
ORANGE,
CA
92665
|
|
Applicant Contact |
HOWARD D BALSHAN |
Correspondent |
INVENTORY SUPPLY CORP. |
1633 E. LINCOLN AVE. |
ORANGE,
CA
92665
|
|
Correspondent Contact |
HOWARD D BALSHAN |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/10/1987 |
Decision Date | 06/03/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|