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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 K193031
Device Name EXPD 4343P, EXPD 3643P
Applicant
DRTECH Corporation
Suite #1, 1 Floor / Suite #2, 3 Floor, 29,
Dunchon-Daero541 Beon-Gil
Jungwon-Gu, Seongam-Si,  KR 13216
Applicant Contact Dongwook Shin
Correspondent
DRTECH Corporation
Suite #1, 1 Floor / Suite #2, 3 Floor, 29,
Dunchon-Daero541 Beon-Gil
Jungwon-Gu, Seongam-Si,  KR 13216
Correspondent Contact Dongwook Shin
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/30/2019
Decision Date 11/22/2019
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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