The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Ultrasonic Surgical System.
| Device ID | K031305 |
| 510k Number | K031305 |
| Device Name: | OLYMPUS ULTRASONIC SURGICAL SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak OLYMPUS OPTICAL CO., LTD. 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 | 2003-04-24 |
| Decision Date | 2003-09-23 |
| Summary: | summary |