Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K031500 |
Device Name |
EXCEL PRIMARY SOLUTION SET |
Applicant |
EXELINT INTL. CO. |
5840 WEST CENTINELA AVE. |
LOS ANGELES,
CA
90045
|
|
Applicant Contact |
ARMAND HAMID |
Correspondent |
EXELINT INTL. CO. |
5840 WEST CENTINELA AVE. |
LOS ANGELES,
CA
90045
|
|
Correspondent Contact |
ARMAND HAMID |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/13/2003 |
Decision Date | 07/25/2003 |
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
|
|
|