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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 K153201
Device Name SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System
Applicant
Sd Biosensor
C-4th & 5th, 16, Deogyeong-Daero,
1556beon-Gil, Yeongtong-Gu,
Suwon-Si,  KR 443-813
Applicant Contact Yeon Park
Correspondent
LK Consulting Group USA, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received11/04/2015
Decision Date 06/24/2016
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
Predetermined Change
Control Plan Authorized		 No
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