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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 K111583
Device Name FLAATZ 560
Applicant
DRTECH CORP.
333-1, SANGDEAWON 1-DONG
JUNGWON-GU
SEONGNAM-SHI, GYEONGGI-DO,  KR 462-807
Applicant Contact CHOUL-WOO SHIN
Correspondent
DRTECH CORP.
333-1, SANGDEAWON 1-DONG
JUNGWON-GU
SEONGNAM-SHI, GYEONGGI-DO,  KR 462-807
Correspondent Contact CHOUL-WOO SHIN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received06/07/2011
Decision Date 10/04/2011
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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