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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K162660
Device Name Green Smart (Model: PHT-35LHS)
Applicant
VATECH Co., Ltd.
13, Samsung 1-Ro 2-Gil
Hwaseong-Si,  KR 445-170
Applicant Contact Daniel Kim
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received09/26/2016
Decision Date 10/20/2016
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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