OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P

Gastroscope And Accessories, Flexible/rigid

OLYMPUS OPTICAL CO., LTD.

The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Ultrasonic Gastrovideoscope Gf Type Uc140p-do5 & Olympus Ultrasonic Gastrofiberscope Gf Type Uc30p.

Pre-market Notification Details

Device IDK021886
510k NumberK021886
Device Name:OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tyler
CorrespondentMark Job
TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton,  MN  55112 -1891
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-06-07
Decision Date2002-06-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170356223 K021886 000
04953170356209 K021886 000
04953170356056 K021886 000
04953170355943 K021886 000
04953170328428 K021886 000
04953170063817 K021886 000
04953170062209 K021886 000
04953170062063 K021886 000

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