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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 K240759
Device Name REMEX-GR100
Applicant
Remedi Co., Ltd.
69-14, Sakju-Ro 145beon-Gil
Chuncheon-Si, Gangwon-Do
Seoul,  KR 24232
Applicant Contact Sungho Cho
Correspondent
510K FDA, Inc.
156 E. Granada Blvd.
Ormond Beach,  FL  32176
Correspondent Contact Lee Strong
Regulation Number872.1800
Classification Product Code
EHD  
Date Received03/20/2024
Decision Date 05/13/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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