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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 K170066
Device Name Green16/Green18 (Model: PHT-65LHS)
Applicant
VATECH CO., LTD.
13, Samsung 1-ro 2-gil
Hwaseong-si,  KR 445-170
Applicant Contact Daniel Kim
Correspondent
MTECH GROUP
8310 BUFFALO SPEEDWAY
HOUSTON,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received01/09/2017
Decision Date 06/16/2017
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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