Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2

Gastroscope And Accessories, Flexible/rigid

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Distal Cap Model Dh-32en, Distal Cap Model Dh-17en2.

Pre-market Notification Details

Device IDK212296
510k NumberK212296
Device Name:Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
ClassificationGastroscope 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 CodeFDS  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-22
Decision Date2021-08-19

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