Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K904685 |
Device Name |
EXEL HUBER INFUSION SET WITHOUT INJECTION SITE (Y) |
Applicant |
EXEL INTL. |
P.O. BOX 3194 |
CULVER CITY,
CA
90231 -3194
|
|
Applicant Contact |
HAMID |
Correspondent |
EXEL INTL. |
P.O. BOX 3194 |
CULVER CITY,
CA
90231 -3194
|
|
Correspondent Contact |
HAMID |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 10/04/1990 |
Decision Date | 11/21/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|