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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 K192338
Device Name NEOLab Clear Aligners
Applicant
New England Ortho Lab, Inc.
3 Riverside Dr.
Andover,  MA  01810
Applicant Contact Olivia Channon
Correspondent
Qserve Group, Us, Inc.
7949 Beaumont Green E. Dr.
Indianapolis,  IN  46250
Correspondent Contact Patsy J Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received08/28/2019
Decision Date 03/12/2020
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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