Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K081361 |
Device Name |
CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX |
Applicant |
ICU MEDICAL INC |
4455 ATHERTON DRIVE |
SALT LAKE CITY,
UT
84123
|
|
Applicant Contact |
TRACY BEST |
Correspondent |
ICU MEDICAL INC |
4455 ATHERTON DRIVE |
SALT LAKE CITY,
UT
84123
|
|
Correspondent Contact |
TRACY BEST |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/15/2008 |
Decision Date | 08/28/2008 |
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
|
|
|