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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 Management, Ophthalmic
510(k) Number K191615
Device Name Huvitz Imaging System
Applicant
Huvitz Co., Ltd.
38, Burim-Ro, 170beon-Gil, Dongan-Gu
Anyang-Si, Dongan-Gu,  KR 14055
Applicant Contact Hyung Min Heo
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received06/18/2019
Decision Date 07/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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