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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K200271
Device Name rainbow CT
Applicant
Dentium Co., Ltd (Ict Branch)
76, Changnyong-Daero 256beon-Gil, Yeongtong-Gu
Suwon-Si,  KR 16229
Applicant Contact Sangwoo Lee
Correspondent
Mtechgroup
7707 Fannin St. Suite 200 V111
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received02/04/2020
Decision Date 04/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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