Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K143087 |
Device Name |
Hospira Blood Set |
Applicant |
HOSPIRA, INC. |
375 FIELD DRIVE |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
Charles Neitzel |
Correspondent |
ICU Medical Inc |
600 N. Field Drive |
Lake Forest,
IL
60045
|
|
Correspondent Contact |
Jeannette Marinoni |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/27/2014 |
Decision Date | 03/04/2015 |
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
|
|
|