OES THORACOSCOPE SYSTEM

Mediastinoscope, Surgical

OLYMPUS CORP.

The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Oes Thoracoscope System.

Pre-market Notification Details

Device IDK912362
510k NumberK912362
Device Name:OES THORACOSCOPE SYSTEM
ClassificationMediastinoscope, Surgical
Applicant OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
ContactDaniel J Dillon
CorrespondentDaniel J Dillon
OLYMPUS CORP. 4 NEVADA DR. Lake Success,  NY  11042
Product CodeEWY  
CFR Regulation Number874.4720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-29
Decision Date1991-10-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04042761074032 K912362 000
04042761008679 K912362 000
04042761052771 K912362 000
04042761052764 K912362 000
04042761052757 K912362 000
04042761004961 K912362 000
04042761004954 K912362 000
04042761004886 K912362 000
04042761004800 K912362 000
04042761031035 K912362 000
04042761031042 K912362 000
04042761031059 K912362 000
04042761074025 K912362 000
04042761074018 K912362 000
04042761074001 K912362 000
04042761068796 K912362 000
04042761052801 K912362 000
04042761031097 K912362 000
04042761031080 K912362 000
04042761031073 K912362 000
04042761041539 K912362 000

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