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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Rapid Wax, Dental
510(k) Number K904467
Device Name ARGILITE 3
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 Number872.3060
Classification Product Code
EIT  
Date Received10/01/1990
Decision Date 10/31/1990
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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