Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K120443 |
Device Name |
NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE |
Applicant |
BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
1620 WAUKEGAN ROAD |
BUILDING R |
MCGAW PARK,
IL
60085
|
|
Applicant Contact |
NANETTE HEDDEN |
Correspondent |
BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
1620 WAUKEGAN ROAD |
BUILDING R |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
NANETTE HEDDEN |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 02/14/2012 |
Decision Date | 05/22/2012 |
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
|
|
|