The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Choledochoscope/endoscope Modification.
| Device ID | K933906 |
| 510k Number | K933906 |
| Device Name: | CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Contact | Gary A Adler |
| Correspondent | Gary A Adler FUJINON, INC. 399 PARK AVE. New York, NY 10022 -4689 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-11 |
| Decision Date | 1994-07-08 |