OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597

Gastroscope And Accessories, Flexible/rigid

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Distal Attachment, Models Mh-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597.

Pre-market Notification Details

Device IDK984358
510k NumberK984358
Device Name:OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
ClassificationGastroscope And Accessories, Flexible/rigid
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-07
Decision Date1999-09-17
Summary:summary

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