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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 K161246
Device Name Ez3D-i / E3
Applicant
Ewoosoft Co., Ltd.
801-Ho, 6, Samsung 1-Ro 1-Gil
Hwaseong-Si,  KR 18449
Applicant Contact Young Seok Kim
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt
Suite 417
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received05/03/2016
Decision Date 05/31/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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