Device Classification Name |
system, dialysate delivery, single patient
|
510(k) Number |
K883111 |
Device Name |
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 |
Applicant |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
ROBERT WILKINSON |
Correspondent |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
ROBERT WILKINSON |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 07/25/1988 |
Decision Date | 02/08/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|