AURIUM 68M

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 Aurium 68m.

Pre-market Notification Details

Device IDK952402
510k NumberK952402
Device Name:AURIUM 68M
ClassificationAlloy, Gold-based Noble Metal
Applicant ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego,  CA  92126
ContactManohar Lal Malhotra
CorrespondentManohar 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 Received1995-05-22
Decision Date1995-06-16

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