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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, radiation therapy, radionuclide
510(k) Number K203250
Device Name TaiChiC
Applicant
Our United Corporation
Room 10301, 3rd Floor, Unit 1, Block 28, ShouChuang
International Business Center, No.66
Xi'an,  CN 710018
Applicant Contact Qi Liu
Correspondent
Our United Corporation
Room 10301, 3rd Floor, Unit 1, Block 28, ShouChuang
International Business Center, No.66
Xi'an,  CN 710018
Correspondent Contact Qi Liu
Regulation Number892.5750
Classification Product Code
IWB  
Date Received11/04/2020
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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