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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K183637
Device Name Cruxcan (CRX-1000)
Applicant
Cruxell Corp.
A-405, Migun Techno World Ii 187 Techno 2-Ro, Yuseong-Gu
Daejeon,  KR 34025
Applicant Contact Daeseok Hwang
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.1800
Classification Product Code
MUH  
Date Received12/26/2018
Decision Date 02/12/2019
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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