Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K013714 |
Device Name |
CODAN US I.V. ADMINISTRATION SET, MODEL B400 SP |
Applicant |
CODAN US CORP. |
3511 WEST SUNFLOWER AVE. |
SANTA ANA,
CA
92704 -6944
|
|
Applicant Contact |
MARILYN R POURAZAR |
Correspondent |
CODAN US CORP. |
3511 WEST SUNFLOWER AVE. |
SANTA ANA,
CA
92704 -6944
|
|
Correspondent Contact |
MARILYN R POURAZAR |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 11/08/2001 |
Decision Date | 03/28/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|