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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K201396
Device Name Finetest Lite Smart Blood Glucose Monitoring System
Applicant
OSANG Healthcare Co., Ltd.
132, Anyangcheondong-Ro, Dongan-Gu
Anyang,  KR 14040
Applicant Contact Ik-Hyeon Kim
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt STE 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Date Received05/28/2020
Decision Date 10/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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