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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 K212295
Device Name 21HQ513D
Applicant
Lg Electronics.Inc
77, Sanho-Daero
Gumi-Si,  KR 39381
Applicant Contact Jinhwan Jun
Correspondent
Gms Consulting
4th Floor, Digital Cube, 34, Sangamsan-Ro
Seoul,  KR 03909
Correspondent Contact DoGyun Im
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/22/2021
Decision Date 12/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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