Device Classification Name |
set, administration, for peritoneal dialysis, disposable
|
510(k) Number |
K895631 |
Device Name |
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 |
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 | 876.5630
|
Classification Product Code |
|
Date Received | 09/19/1989 |
Decision Date | 01/29/1990 |
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
|
|
|