The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Visera Cystovideoscope Olympus Cyf Type V/va.
| Device ID | K021074 |
| 510k Number | K021074 |
| Device Name: | VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-02 |
| Decision Date | 2002-05-02 |
| Summary: | summary |