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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleanser, Denture, Over The Counter
510(k) Number K903686
Device Name ARGILITE 4 GOLD ALLOY FOR PORCELAIN
Applicant
Argen Precious Metals, Inc.
8380 Miralani Dr.
San Diego,  CA  92126
Applicant Contact LAL MALHOTRA
Correspondent
Argen Precious Metals, Inc.
8380 Miralani Dr.
San Diego,  CA  92126
Correspondent Contact LAL MALHOTRA
Regulation Number872.3520
Classification Product Code
EFT  
Date Received08/13/1990
Decision Date 08/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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