SONOSURG ULTRASONIC SURGICAL SYSTEM

Instrument, Ultrasonic Surgical

AOMORI OLYMPUS CO., LTD.

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

Pre-market Notification Details

Device IDK041566
510k NumberK041566
Device Name:SONOSURG ULTRASONIC SURGICAL SYSTEM
ClassificationInstrument, Ultrasonic Surgical
Applicant AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactTina Steffanie-oak
CorrespondentTina Steffanie-oak
AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeLFL  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-10
Decision Date2004-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170027123 K041566 000
04953170183171 K041566 000
14953170183123 K041566 000
14953170182959 K041566 000
14953170183215 K041566 000
04953170183072 K041566 000
04953170183058 K041566 000
04953170183034 K041566 000
04953170028533 K041566 000

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