Device Classification Name |
Catheter, Straight
|
510(k) Number |
K080007 |
Device Name |
GRADUATED ADAPTER WITH CLAVE |
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 | 876.5130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/02/2008 |
Decision Date | 05/13/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|