FLOWEASE [SUBCUTANEOUS] INFUSION SET


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

Correspodent Contact niedre m heckman
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 04/10/2012
Decision Date 06/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No