Device Classification Name |
Microfilter, Blood Transfusion
|
510(k) Number |
K904221 |
Device Name |
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS |
Applicant |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
DONALD BUCHHLZ |
Correspondent |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
DONALD BUCHHLZ |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/13/1990 |
Decision Date | 10/26/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|