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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 K942589
Device Name ARGESOL P
Applicant
Argen Precious Metals, Inc.
8380 Miralani Dr.
San Diego,  CA  92126
Applicant Contact MANOHAR L MALHOTRA
Correspondent
Argen Precious Metals, Inc.
8380 Miralani Dr.
San Diego,  CA  92126
Correspondent Contact MANOHAR L MALHOTRA
Regulation Number872.3060
Classification Product Code
EJT  
Date Received06/01/1994
Decision Date 06/22/1994
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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