Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K143015 |
Device Name |
Hospira Primary Sets |
Applicant |
Hospira, Inc. |
375 North Field Drive |
Lake Forest,
IL
60045
|
|
Applicant Contact |
Anju Kurian |
Correspondent |
Hospira, Inc. |
375 North Field Drive |
Lake Forest,
IL
60045
|
|
Correspondent Contact |
Anju Kurian |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/20/2014 |
Decision Date | 02/25/2015 |
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
|
|
|