Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K121092 |
Device Name |
FLOWEASE [SUBCUTANEOUS] INFUSION SET |
Applicant |
BAXTER HEALTHCARE CORP. |
ONE BAXTER WAY |
WESTLAKE VILLAGE,
CA
91362
|
|
Applicant Contact |
NIEDRE M HECKMAN |
Correspondent |
BAXTER HEALTHCARE CORP. |
ONE BAXTER WAY |
WESTLAKE VILLAGE,
CA
91362
|
|
Correspondent Contact |
NIEDRE M HECKMAN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 04/10/2012 |
Decision Date | 06/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|