The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Chf-b20 Choledochoscope.
| Device ID | K904799 |
| 510k Number | K904799 |
| Device Name: | CHF-B20 CHOLEDOCHOSCOPE |
| Classification | Choledochoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FBN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1991-03-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170339561 | K904799 | 000 |
| 04953170071645 | K904799 | 000 |
| 04953170071447 | K904799 | 000 |
| 04953170071072 | K904799 | 000 |
| 04953170069024 | K904799 | 000 |
| 04953170068751 | K904799 | 000 |
| 04953170064517 | K904799 | 000 |
| 14953170042789 | K904799 | 000 |
| 14953170031356 | K904799 | 000 |