The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Colonoscopes.
| Device ID | K112391 |
| 510k Number | K112391 |
| Device Name: | FUJINON COLONOSCOPES |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | FUJINON, INC. 10 HIGH POINT DR. Wayne, NJ 07470 |
| Contact | Gina Walljasper |
| Correspondent | Gina Walljasper FUJINON, INC. 10 HIGH POINT DR. Wayne, NJ 07470 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-19 |
| Decision Date | 2012-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547410323863 | K112391 | 000 |
| 04547410323856 | K112391 | 000 |
| 04547410195743 | K112391 | 000 |