GC Fuji Triage EP

Cement, Dental

GC America Inc.

The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Gc Fuji Triage Ep.

Pre-market Notification Details

Device IDK193484
510k NumberK193484
Device Name:GC Fuji Triage EP
ClassificationCement, Dental
Applicant GC America Inc. 3737 W. 127th Street Alsip,  IL  60780 3
ContactMark Heiss
CorrespondentMark Heiss
GC America Inc. 3737 W. 127th Street Alsip,  IL  60780 3
Product CodeEMA  
CFR Regulation Number872.3275 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-17
Decision Date2020-07-02

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