Device Classification Name |
Set, I.V. Fluid Transfer
|
510(k) Number |
K042410 |
Device Name |
BAXJECT II |
Applicant |
BAXTER HEALTHCARE CORP. |
ONE BAXTER WAY |
WESTLAKE VILLAGE,
CA
91362
|
|
Applicant Contact |
RON LAGERQUIST |
Correspondent |
BAXTER HEALTHCARE CORP. |
ONE BAXTER WAY |
WESTLAKE VILLAGE,
CA
91362
|
|
Correspondent Contact |
RON LAGERQUIST |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/07/2004 |
Decision Date | 10/08/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|