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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 K203797
Device Name vatech A9 (Model : PHT-30CSS)
Applicant
Vatech Co., Ltd
13, Samsung 1-ro 2-gil
Hwaseong-si,  KR 18449
Applicant Contact Daniel Kim
Correspondent
Mtech Group
7707 Fannin St., Ste. 200-V111
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1750
Classification Product Code
OAS  
Date Received12/28/2020
Decision Date 01/25/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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