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
|
|
Correspondent Contact |
NANETTE HEDDEN |
Regulation Number | 880.5440
|
Classification Product Code |
|
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
|
|
|