The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Rigid Ureterorenoscope.
| Device ID | K852888 |
| 510k Number | K852888 |
| Device Name: | OLYMPUS RIGID URETERORENOSCOPE |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Scott J Solano |
| Correspondent | Scott J Solano OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-09 |
| Decision Date | 1985-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761003353 | K852888 | 000 |