Device Classification Name |
Saline, Vascular Access Flush
|
510(k) Number |
K090882 |
Device Name |
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE |
Applicant |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
D-389, BLDG., H2 |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
KEITH DUNN |
Correspondent |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
D-389, BLDG., H2 |
LAKE FOREST,
IL
60045
|
|
Correspondent Contact |
KEITH DUNN |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/31/2009 |
Decision Date | 04/23/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|