The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon G5 Bronchoscopes, Models Eb-470s, Eb-250s, And Eb-270p.
| Device ID | K050907 |
| 510k Number | K050907 |
| Device Name: | FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | FUJINON, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary FUJINON, INC. 543 LONG HILL AVENUE Shelton, CT 06484 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-11 |
| Decision Date | 2005-05-19 |
| Summary: | summary |