The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Ultrasonic Surgical System.
| Device ID | K021962 |
| 510k Number | K021962 |
| Device Name: | OLYMPUS ULTRASONIC SURGICAL SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville, NY 11747 |
| 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 | 2002-06-14 |
| Decision Date | 2003-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170028533 | K021962 | 000 |
| 14953170062602 | K021962 | 000 |