AUROLITE 55

Alloy, Gold-based Noble Metal

ARGEN PRECIOUS METALS, INC.

The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Aurolite 55.

Pre-market Notification Details

Device IDK950858
510k NumberK950858
Device Name:AUROLITE 55
ClassificationAlloy, Gold-based Noble Metal
Applicant ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego,  CA  92126
ContactManohar L Malhotra
CorrespondentManohar L Malhotra
ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego,  CA  92126
Product CodeEJT  
CFR Regulation Number872.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-27
Decision Date1995-03-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.