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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 K190096
Device Name R2GATE
Applicant
Megagen Implant Co., Ltd.
41940, 10f, 12 Gong Pyeong Ro, Jung Gu
Daegu,  KR 41940
Applicant Contact HyeJin Jung
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/22/2019
Decision Date 06/26/2019
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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