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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 K203339
Device Name NEOLab Clear Aligners
Applicant
New England Ortho Lab, Inc
3 Riverside Drive
Andover,  MA  01810
Applicant Contact Christian Saurman
Correspondent
New England Ortho Lab, Inc
3 Riverside Drive
Andover,  MA  01810
Correspondent Contact Olivia Channon
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/12/2020
Decision Date 01/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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