The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Infant Resectoscope And Accessories.
| Device ID | K904940 |
| 510k Number | K904940 |
| Device Name: | OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES |
| Classification | Resectoscope |
| 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 | FJL |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-01 |
| Decision Date | 1992-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761005319 | K904940 | 000 |
| 04042761005302 | K904940 | 000 |
| 04042761005296 | K904940 | 000 |
| 04042761005289 | K904940 | 000 |
| 04042761005272 | K904940 | 000 |
| 04042761003803 | K904940 | 000 |
| 04042761003797 | K904940 | 000 |