The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Oes Urology.
| Device ID | K950719 |
| 510k Number | K950719 |
| Device Name: | OES UROLOGY |
| Classification | Urethrotome |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | EZO |
| CFR Regulation Number | 876.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-16 |
| Decision Date | 1996-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761000697 | K950719 | 000 |
| 04042761000406 | K950719 | 000 |