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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K223789
Device Name 21HQ513D
Applicant
Lg Electronics.Inc
168, Suchul-Daero
Gumi-Si,  KR 39368
Applicant Contact Jinhwan Jun
Correspondent
Lg Electronics
222, Lg-Ro, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Correspondent Contact Daseul An
Regulation Number892.2050
Classification Product Code
PGY  
Date Received12/19/2022
Decision Date 01/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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