G-LIGHT

Activator, Ultraviolet, For Polymerization

GC AMERICA, INC.

The following data is part of a premarket notification filed by Gc America, Inc. with the FDA for G-light.

Pre-market Notification Details

Device IDK050059
510k NumberK050059
Device Name:G-LIGHT
ClassificationActivator, Ultraviolet, For Polymerization
Applicant GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
ContactTerry Joritz
CorrespondentTerry Joritz
GC AMERICA, INC. 3737 WEST 127TH ST. Alsip,  IL  60803
Product CodeEBZ  
CFR Regulation Number872.6070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-11
Decision Date2005-02-03

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