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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K211159
Device Name eco-x Series (eco-x, eco-x-s)
Applicant
Hdx Will Corp.
#105,106,201,202,203,204,38,Osongsaengmyeong-4-Ro
Osong-Eup,Heungdeok-Gu
Cheongju-Si,  KR 28161
Applicant Contact Myoung-Joon Lee
Correspondent
Hdx Will Corp.
03162 10f, 29, Insadong 5-Gil
Jongno-Gu,  KR 03162
Correspondent Contact Jeon Seounghwa
Regulation Number892.1750
Classification Product Code
OAS  
Date Received04/19/2021
Decision Date 12/30/2021
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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