Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K142367 |
Device Name |
Hospira Primary Sets |
Applicant |
HOSPIRA, INC. |
375 N. FIELD DRIVE |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
CATHERINE KANG |
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 | 08/25/2014 |
Decision Date | 11/25/2014 |
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
|
|
|