The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon G5 Duodenscopes; G5 Duodenoscopes, Ed-450xt5, Ed-250xt5.
| Device ID | K042076 |
| 510k Number | K042076 |
| Device Name: | FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | FUJINON, INC. P.O. BOX 2156 Huntington, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary FUJINON, INC. P.O. BOX 2156 Huntington, CT 06484 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-02 |
| Decision Date | 2004-11-18 |
| Summary: | summary |