Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K101677 |
Device Name |
HOSPIRA INFUSION BLOOD SETS |
Applicant |
HOSPIRA, INC. |
375 N FIELD DRIVE |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
KAREN KEENER |
Correspondent |
HOSPIRA, INC. |
375 N FIELD DRIVE |
LAKE FOREST,
IL
60045
|
|
Correspondent Contact |
KAREN KEENER |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 06/15/2010 |
Decision Date | 08/11/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|