The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Duodenoscope Model.
| Device ID | K181745 |
| 510k Number | K181745 |
| Device Name: | FUJIFILM Duodenoscope Model |
| Classification | Duodenoscope And Accessories, Flexible/rigid |
| Applicant | FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun, JP 258-8538 |
| Contact | Randy Vader |
| Correspondent | Jeffrey Wan FUJIFILM Medical Systems U.S.A., Inc. 40 Boroline Road Allendale, NJ 07401 |
| Product Code | FDT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2019-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410359282 | K181745 | 000 |
| 04547410330663 | K181745 | 000 |