Device Classification Name |
Duodenoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K042076 |
FOIA Releasable 510(k) |
K042076
|
Device Name |
FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 |
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 |
|
Date Received | 08/02/2004 |
Decision Date | 11/18/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|