FUJIFILM Distal End Cap

Duodenoscope And Accessories, Flexible/rigid

Fujifilm Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Fujifilm Distal End Cap.

Pre-market Notification Details

Device IDK203028
510k NumberK203028
Device Name:FUJIFILM Distal End Cap
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant Fujifilm Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeFDT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-02
Decision Date2020-10-30

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