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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 K201777
Device Name 31HN713D
Applicant
LG Electronics Inc.
222, LG-ro, Cheongho-ri, Jinwi-myeon
Pyeongtaek-Si,  KR 17709
Applicant Contact Jinhwan Jun
Correspondent
LG Electronics Inc.
222, LG-ro, Cheongho-ri, Jinwi-myeon
Pyeongtaek-Si,  KR 17709
Correspondent Contact Jinhwan Jun
Regulation Number892.2050
Classification Product Code
PGY  
Date Received06/29/2020
Decision Date 10/08/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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