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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K161063
Device Name EzRay Air (Model VEX-P300)
Applicant
VATECH Co., Ltd.
13, Samsung 1-Ro 2-Gil
Hwaseong-Si,  KR 18449
Applicant Contact Daniel Kim
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number872.1800
Classification Product Code
EHD  
Date Received04/15/2016
Decision Date 09/01/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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