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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name alloy, gold-based noble metal
510(k) Number K931475
Device Name ARGELITE 55
Original Applicant
ARGEN PRECIOUS METALS, INC.
8380 miralani dr.
san diego,  CA  92126
Original Contact manohar malhotra
Regulation Number872.3060
Classification Product Code
EJT  
Date Received03/24/1993
Decision Date 07/08/1993
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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