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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 K132842
Device Name FLAATZ 600 SERIES (FLAATZ 600/601)
Applicant
Drtech Corp.
333-1, Sangdaewon1-Dong
Jungwon-Gu
Seongnam-Shi, Gyeonggi-Do,  KR 462-807
Applicant Contact CHOUL-WOO SHIN
Correspondent
Drtech Corp.
333-1, Sangdaewon1-Dong
Jungwon-Gu
Seongnam-Shi, Gyeonggi-Do,  KR 462-807
Correspondent Contact CHOUL-WOO SHIN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/10/2013
Decision Date 02/21/2014
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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