Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K090189 |
Device Name |
ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE |
Applicant |
ICU MEDICAL, INC |
4455 ATHERTON DR. |
SALT LAKE CITY,
UT
84123
|
|
Applicant Contact |
TRACY BEST |
Correspondent |
ICU MEDICAL, INC |
4455 ATHERTON DR. |
SALT LAKE CITY,
UT
84123
|
|
Correspondent Contact |
TRACY BEST |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/26/2009 |
Decision Date | 04/10/2009 |
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
|
|
|