The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon G5 Colonoscopes, Models Ec-450hl5 And Ec-250hl5.
| Device ID | K041903 |
| 510k Number | K041903 |
| Device Name: | FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | FUJINON, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph M Azary |
| Correspondent | Joseph M Azary FUJINON, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-14 |
| Decision Date | 2004-11-10 |
| Summary: | summary |