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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K171295
Device Name ULab Systems Treatment Planning Software
Applicant
Ulab Systems, Inc.
101 Jefferson Dr., Suite 212a
Menlo Park,  CA  95025
Applicant Contact Charlie Wen
Correspondent
Ulab Systems, Inc.
101 Jefferson Dr., Suite 212a
Menlo Park,  CA  95025
Correspondent Contact Charlie Wen
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received05/02/2017
Decision Date 01/09/2018
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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