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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 K200018
Device Name HAD1717MC
Applicant
H&Abyz
1f, 2-Dong, 41-16 Cheoinseong-Ro, Namsa-Myeon, Cheoin-Gu
Yongin-Si,  KR 17118
Applicant Contact Nam Kyu Hur
Correspondent
Withus Group, Inc.
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/03/2020
Decision Date 01/31/2020
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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