Device Classification Name |
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
|
510(k) Number |
K880102 |
Device Name |
BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS |
Applicant |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
ROBERT L WILKINSON |
Correspondent |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
ROBERT L WILKINSON |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 01/12/1988 |
Decision Date | 05/26/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|