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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K190357
Device Name Star-X, Intraoral X-ray System
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.
#105,106,201,202,203,204,38,Osongsaengmyeong-4-Ro
Osong-Eup,Heungdeok-Gu
Cheongju-Si,  KR 28161
Correspondent Contact Myoung-Joon Lee
Regulation Number872.1800
Classification Product Code
EHD  
Date Received02/15/2019
Decision Date 03/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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