INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR


Device Classification Name

set, administration, intravascular

510(k) Number K121634
Device Name INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR
Applicant
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake, 
IL 
60073

Applicant Contact nanette hedden
Correspondent
BAXTER HEALTHCARE CORPORATION
25212 w. illinois route 120
round lake, 
IL 
60073

Correspodent Contact nanette hedden
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 06/04/2012
Decision Date 06/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Special
Reviewed by Third Party No

Combination Product

No