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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 K192596
Device Name ULab Systems Dental Aligner Kit
Applicant
Ulab Systems, Inc.
6 Lagoon Dr., Suite 180
Redwood City,  CA  94065
Applicant Contact Charlie Wen
Correspondent
Sylvia Erickson Consulting
157 Ruby Ave.
San Carlos,  CA  94070
Correspondent Contact Sylvia Erickson
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/20/2019
Decision Date 02/11/2020
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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