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 |