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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 K192700
Device Name Xcam
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 Received09/26/2019
Decision Date 12/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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