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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bracket, ceramic, orthodontic
510(k) Number K173440
Device Name Carriere SLX 3D Clear
Applicant
Ortho Organizers, Inc.
1822 Aston Avenue
Carlsbad,  CA  92008
Applicant Contact Colleen Boswell
Correspondent
Ortho Organizers, Inc.
1822 Aston Avenue
Carlsbad,  CA  92008
Correspondent Contact Colleen Boswell
Regulation Number872.5470
Classification Product Code
NJM  
Date Received11/06/2017
Decision Date 03/08/2018
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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