Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K012879 |
Device Name |
EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE |
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 | 08/28/2001 |
Decision Date | 01/17/2002 |
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
|
|
|