Device Classification Name |
Enteroscope And Accessories
|
510(k) Number |
K040048 |
Device Name |
FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM |
Applicant |
FUJINON, INC. |
P.O. BOX 2156 |
HUNTINGTON,
CT
06484
|
|
Applicant Contact |
JOSEPH M AZARY |
Correspondent |
FUJINON, INC. |
P.O. BOX 2156 |
HUNTINGTON,
CT
06484
|
|
Correspondent Contact |
JOSEPH M AZARY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/12/2004 |
Decision Date | 06/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|