The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Colonoscope For Double Balloon Enterscopy System Model, Ec-450b15.
| Device ID | K090116 |
| 510k Number | K090116 |
| Device Name: | FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | FUJINON, INC. 1-324 UETAKE-CHO Kita- Ku Saitama, JP 331-9624 |
| Contact | Masayuki Ooyatsu |
| Correspondent | Masayuki Ooyatsu FUJINON, INC. 1-324 UETAKE-CHO Kita- Ku Saitama, JP 331-9624 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-21 |
| Decision Date | 2009-04-22 |
| Summary: | summary |