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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K242709
Device Name JLK-PWI
Applicant
JLK, Inc.
Jlk Tower, 5, Teheran-Ro 33-Gil
Gangnam-Gu
Seoul,  KR 06141
Applicant Contact Dongmin Kim
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/09/2024
Decision Date 11/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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