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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 K213497
Device Name ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
Applicant
H&Abyz Co., Ltd.
If, 2-Dong, 41-16 Cheoinseong-Ro Namsa-Myeon, Cheoin-Gu
Yongin-Si,  KR 17118
Applicant Contact Hyunook (David) Han
Correspondent
H&Abyz Co., Ltd.
If, 2-Dong, 41-16 Cheoinseong-Ro Namsa-Myeon, Cheoin-Gu
Yongin-Si,  KR 17118
Correspondent Contact Hyunook (David) Han
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/01/2021
Decision Date 11/15/2021
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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