The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Inc. G5 Gastroscopes, Models Ec-450wr5, Ec-250wr5.
| Device ID | K042043 |
| 510k Number | K042043 |
| Device Name: | FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 |
| Classification | Gastroscope 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 | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-29 |
| Decision Date | 2004-11-24 |
| Summary: | summary |