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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K140894
Device Name ARGEN PMMA
Applicant
The Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Applicant Contact CRAIG JOLICOEUR
Correspondent
The Argen Corporation
5855 Oberlin Dr.
San Diego,  CA  92121
Correspondent Contact CRAIG JOLICOEUR
Regulation Number872.3770
Classification Product Code
EBG  
Date Received04/08/2014
Decision Date 07/31/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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