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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K200787
Device Name BSD3543W
Applicant
Bontech Co., Ltd.
Digital Empire D-Bldg. #1201, Deogyeong-Daero
1556 Beon-Gil, Yeongtong-Gu
Suwon-Si,  KR 443-702
Applicant Contact Ki Chan Ahn
Correspondent
Mtechgroup
7707 Fannin St. Suite 200
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/26/2020
Decision Date 04/23/2020
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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