The following data is part of a premarket notification filed by Expanded Optics, Inc. with the FDA for Omni Cystoscope.
| Device ID | K922320 |
| 510k Number | K922320 |
| Device Name: | OMNI CYSTOSCOPE |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | EXPANDED OPTICS, INC. 7382 BOLSA AVE. Westminster, CA 92683 |
| Contact | Anita Thibeault |
| Correspondent | Anita Thibeault EXPANDED OPTICS, INC. 7382 BOLSA AVE. Westminster, CA 92683 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-18 |
| Decision Date | 1993-01-13 |