AUROLITE 9

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 9.

Pre-market Notification Details

Device IDK940610
510k NumberK940610
Device Name:AUROLITE 9
ClassificationAlloy, Gold-based Noble Metal
Applicant ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego,  CA  92126
ContactDr.manohar L Malhotra
CorrespondentDr.manohar 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 Received1994-02-14
Decision Date1994-03-17

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