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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 K211317
Device Name CRUXVIEW
Applicant
CRUXELL Corp.
405, Migun techno World II, 187, Techno 2-ro Yuseong-gu
Daejeon,  KR 34025
Applicant Contact Boeun Bang
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt, STE 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/30/2021
Decision Date 07/29/2021
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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