OLYMPUS ULTRASONIC SURGICAL SYSTEM

Instrument, Ultrasonic Surgical

THE OLYMPUS OPTICAL CO.

The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Olympus Ultrasonic Surgical System.

Pre-market Notification Details

Device IDK021962
510k NumberK021962
Device Name:OLYMPUS ULTRASONIC SURGICAL SYSTEM
ClassificationInstrument, Ultrasonic Surgical
Applicant THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville,  NY  11747
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
THE OLYMPUS OPTICAL CO. TWO CORPORATE DR. Melville,  NY  11747
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-14
Decision Date2003-02-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170028533 K021962 000
14953170062602 K021962 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.