Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K992039 |
Device Name |
EXEL I.V. BLOOD LINE 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 | 876.5820
|
Classification Product Code |
|
Date Received | 06/17/1999 |
Decision Date | 02/10/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|