Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K963659 |
Device Name |
EXEL I.V. ADMINISTRATION SET |
Applicant |
EXEL INTL. |
P.O. BOX 3194 |
CULVER CITY,
CA
90231 -3194
|
|
Applicant Contact |
ARMAND HAMID |
Correspondent |
EXEL INTL. |
P.O. BOX 3194 |
CULVER CITY,
CA
90231 -3194
|
|
Correspondent Contact |
ARMAND HAMID |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/03/1996 |
Decision Date | 12/16/1997 |
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
|
|
|