The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Model Eg-530n Trans Nasal Insertion.
| Device ID | K063316 |
| 510k Number | K063316 |
| Device Name: | FUJINON MODEL EG-530N TRANS NASAL INSERTION |
| Classification | Gastroscope And Accessories, Flexible/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 | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-02 |
| Decision Date | 2007-03-16 |
| Summary: | summary |