FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM

Enteroscope And Accessories

FUJINON, INC.

The following data is part of a premarket notification filed by Fujinon, Inc. with the FDA for Fujinon Double Balloon Enteroscopy System.

Pre-market Notification Details

Device IDK040048
510k NumberK040048
Device Name:FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM
ClassificationEnteroscope And Accessories
Applicant FUJINON, INC. P.O. BOX 2156 Huntington,  CT  06484
ContactJoseph M Azary
CorrespondentJoseph M Azary
FUJINON, INC. P.O. BOX 2156 Huntington,  CT  06484
Product CodeFDA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-12
Decision Date2004-06-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04547410330960 K040048 000
04547410330953 K040048 000
04547410331370 K040048 000

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