The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Flexible And Rigid Ureterotome System.
| Device ID | K904939 |
| 510k Number | K904939 |
| Device Name: | FLEXIBLE AND RIGID URETEROTOME SYSTEM |
| Classification | Urethrotome |
| 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 | EZO |
| CFR Regulation Number | 876.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-01 |
| Decision Date | 1992-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14042761030608 | K904939 | 000 |
| 04042761023146 | K904939 | 000 |
| 04042761023139 | K904939 | 000 |