Initial LiSi Press

Powder, Porcelain

GC AMERICA INC.

The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Initial Lisi Press.

Pre-market Notification Details

Device IDK153136
510k NumberK153136
Device Name:Initial LiSi Press
ClassificationPowder, Porcelain
Applicant GC AMERICA INC. 3737 W. 127TH STREET Alsip,  IL  60803
ContactMark Heiss
CorrespondentMark Heiss
GC AMERICA INC. 3737 W. 127TH STREET Alsip,  IL  60803
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-30
Decision Date2016-06-30
Summary:summary

NIH GUDID Devices

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