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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K180767
Device Name FEMON Banana Thermometer
Applicant
Life Science Technology, Inc.
Suite B-1207, Gangseo Hangang Xi Tower, Yangcheon-Ro 401,
Gangseo-Gu
Seoul,  KR 07528
Applicant Contact Jaewoo Jun
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
690 Roosevelt,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/23/2018
Decision Date 01/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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