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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 K160204
Device Name BSD4343 Digital Flat Panel X-ray Detector
Applicant
Bontech, Inc.
Youngtong-Gu Youngtong-Dong 980-3
Digital Empire D #1201
Suwon-Si,  KR 443-702
Applicant Contact Kwang S. Choi
Correspondent
Mtechgroup
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/28/2016
Decision Date 06/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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