AIGIS-PT

Alloy, Gold-based Noble Metal

SB LUCIUS, INC.

The following data is part of a premarket notification filed by Sb Lucius, Inc. with the FDA for Aigis-pt.

Pre-market Notification Details

Device IDK024144
510k NumberK024144
Device Name:AIGIS-PT
ClassificationAlloy, Gold-based Noble Metal
Applicant SB LUCIUS, INC. 9778 KATELLA AVE. STE. 205 Anaheim,  CA  92804
ContactDae-kyu Chang
CorrespondentDae-kyu Chang
SB LUCIUS, INC. 9778 KATELLA AVE. STE. 205 Anaheim,  CA  92804
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-16
Decision Date2003-03-07
Summary:summary

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