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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K180671
Device Name MINE
Applicant
Rht Co., Ltd.
207, Cheomdangwagiro, 208 Bungil 50, Bukgu
Gwangju,  KR 61012
Applicant Contact Joon-Ho Oh
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/14/2018
Decision Date 06/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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