OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS

Duodenoscope 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 Tjf-140r/jf-140r Evis Duodenovideoscopes And Accessories, Olympus Maj-311/maj-411 Distal Covers.

Pre-market Notification Details

Device IDK980465
510k NumberK980465
Device Name:OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactLaura Storms-tayler
CorrespondentLaura Storms-tayler
OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-05
Decision Date1998-04-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170368612 K980465 000
04953170339851 K980465 000
14953170194648 K980465 000
04953170071416 K980465 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.