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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K191026
Device Name MEDIP PRO
Applicant
Medical IP Co., Ltd.
7f Changkyung Bldg., 174, Yulgok-Ro
Jongno-Gu,  KR 03127
Applicant Contact Yoon Bo Chung
Correspondent
Dt&S Co., Ltd.
#202, Mario Tower, 28, Digital-Ro 30-Gil
Guro-Gu,  KR 08389
Correspondent Contact GeumHyeon Kim
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/18/2019
Decision Date 11/07/2019
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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