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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K182348
Device Name 14HK701G-W
Applicant
LG Electronics Inc.
222, LG-Ro
Jinwi-Myeon Pyeongtaek-Si,  KR 17709
Applicant Contact Jinhwan Jun
Correspondent
LG Electronics Inc.
222, LG-Ro
Jinwi-Myeon Pyeongtaek-Si,  KR 17709
Correspondent Contact Jinhwan Jun
Regulation Number892.1680
Classification Product Code
MQB  
Date Received08/29/2018
Decision Date 10/18/2018
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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