Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K033301 |
Device Name |
IV ADMINISTRATION AND CONNECT SETS |
Applicant |
CODAN US CORP. |
3511 WEST SUNFLOWER AVE. |
SANTA ANA,
CA
92704 -6944
|
|
Applicant Contact |
ROHIT PATEL |
Correspondent |
CODAN US CORP. |
3511 WEST SUNFLOWER AVE. |
SANTA ANA,
CA
92704 -6944
|
|
Correspondent Contact |
ROHIT PATEL |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/14/2003 |
Decision Date | 03/04/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|