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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 K162609
Device Name ClearPath Aligner
ClearPath Orthodontics Ltd
6-N, Main Boulevard
Johar Town,  PK
Applicant Contact Waqas Wahab
Qserve Group US, Inc.
5600 Wisconsin Avenue, #509
Chevy Chase,  MD  20815
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
Date Received09/19/2016
Decision Date 07/06/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No