Device Classification Name |
Pump, Infusion
|
510(k) Number |
K915523 |
Device Name |
FLO-GARD(R) 6301 |
Applicant |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Applicant Contact |
PATRICIA S BARSANTI |
Correspondent |
BAXTER HEALTHCARE CORP. |
ROUTE 120 AND WILSON RD. |
ROUND LAKE,
IL
60073
|
|
Correspondent Contact |
PATRICIA S BARSANTI |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 12/10/1991 |
Decision Date | 02/28/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|