AUROLITE 85

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 85.

Pre-market Notification Details

Device IDK940360
510k NumberK940360
Device Name:AUROLITE 85
ClassificationAlloy, Gold-based Noble Metal
Applicant ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego,  CA  92126
ContactDr. Manohar Lal Malhotra
CorrespondentDr. Manohar Lal 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 Received1994-01-26
Decision Date1994-03-04

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