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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 K211791
Device Name Ez3D-i/E3
Applicant
Ewoosoft Co., Ltd
801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil
Hwaseong-si,  KR 18449
Applicant Contact Young Seok Kim
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave. STE 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/10/2021
Decision Date 08/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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