The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Olympus Ultrasonic Surgical System Sonosurg.
| Device ID | K050885 |
| 510k Number | K050885 |
| Device Name: | OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS MEDICAL SYSTEMS CORPORATION TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-07 |
| Decision Date | 2005-06-03 |
| Summary: | summary |