SONOSURG TROCAR

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 Trocar.

Pre-market Notification Details

Device IDK042160
510k NumberK042160
Device Name:SONOSURG TROCAR
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 Received2004-08-10
Decision Date2005-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170208482 K042160 000
14953170170499 K042160 000
14953170061674 K042160 000
14953170445818 K042160 000

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