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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 K961211
Device Name ARGELITE 52+
Applicant
Argen Precious Metals, Inc.
5855 Oberlin Dr.
San Diego,  CA  92121
Applicant Contact PAUL CASCONE
Correspondent
Argen Precious Metals, Inc.
5855 Oberlin Dr.
San Diego,  CA  92121
Correspondent Contact PAUL CASCONE
Regulation Number872.3060
Classification Product Code
EJT  
Date Received03/28/1996
Decision Date 04/25/1996
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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