Device Classification Name |
Needle, Fistula
|
510(k) Number |
K903945 |
Device Name |
EXEL A-V FISTULA SET |
Applicant |
EXEL INTL. |
P.O. BOX 3194 |
CULVER CITY,
CA
90231 -3194
|
|
Applicant Contact |
ESHAGH HAMID |
Correspondent |
EXEL INTL. |
P.O. BOX 3194 |
CULVER CITY,
CA
90231 -3194
|
|
Correspondent Contact |
ESHAGH HAMID |
Regulation Number | 876.5540
|
Classification Product Code |
|
Date Received | 08/27/1990 |
Decision Date | 11/20/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|