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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aligner, sequential
510(k) Number K183229
Device Name Argen Clear Aligner
Applicant
Argen Corporation
5855 Oberlin Drive
San Diego,  CA  92121
Applicant Contact Paul Cascone
Correspondent
Qserve Group US, Inc.
5600 Wisconsin Avenue, #509
Chevy Chase,  MD  20815
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/20/2018
Decision Date 06/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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