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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 K190948
Device Name Magic Clear Aligners
Applicant
Voodoo Manufacturing, Inc.
361 Stagg Street #408
Brooklyn,  NY  11206 2
Applicant Contact Max Friefeld
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.5470
Classification Product Code
NXC  
Date Received04/11/2019
Decision Date 05/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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