Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K052722 |
Device Name |
LIFESHIELD LATEX-FREE MICROBORE EXTENSION SET, MODEL 14949 AND OTHERS |
Applicant |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
LAKE FOREST,
IL
60045
|
|
Applicant Contact |
THOMAS KOZMA |
Correspondent |
HOSPIRA, INC. |
275 NORTH FIELD DR. |
LAKE FOREST,
IL
60045
|
|
Correspondent Contact |
THOMAS KOZMA |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2005 |
Decision Date | 11/02/2005 |
Decision |
SE - With Limitations
(SESU) |
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
|
|
|