Balloon BS-3

Enteroscope And Accessories

FUJIFILM Corporation

The following data is part of a premarket notification filed by Fujifilm Corporation with the FDA for Balloon Bs-3.

Pre-market Notification Details

Device IDK213195
510k NumberK213195
Device Name:Balloon BS-3
ClassificationEnteroscope And Accessories
Applicant FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-gun,  JP 258-8538
ContactRandy Vader
CorrespondentJeffrey Wan
FUJIFILM Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 Lexington,  MA  02421
Product CodeFDA  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2021-10-29

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