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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 K162850
Device Name GuideMia Ortho+
Applicant
GUIDEMIA TECHNOLOGIES, LLC
5030 KATELLA AVE., STE 209
LOS ALAMITOS,  CA  90720
Applicant Contact FEI GAO
Correspondent
GUIDEMIA TECHNOLOGIES, LLC
5030 KATELLA AVE., STE 209
LOS ALAMITOS,  CA  90720
Correspondent Contact FEI GAO
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received10/11/2016
Decision Date 03/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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