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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 K183695
Device Name OrthoAnalysis Software
Applicant
Inteware Co., Ltd.
4F., No.93, Xinzheng 5th St., Taiwan, R.O.C.
Minxiong Township, Chiayi Country 62145,  CN 621
Applicant Contact Wayne Tsai
Correspondent
Inteware Co., Ltd.
4F., No.93, Xinzheng 5th St., Taiwan, R.O.C.
Minxiong Township, Chiayi Country 62145,  CN 621
Correspondent Contact Wayne Tsai
Regulation Number872.5470
Classification Product Code
PNN  
Date Received12/31/2018
Decision Date 09/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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