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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K171890
Device Name BEXCORE Breast Biopsy System, Biopsy Needle
Applicant
Medical Park CO., LTD
#624, Knowlegdge Industry Center
Bundang-Suji, U-Tower 767,Sinsu-ro, Suji-gu
Yongin-si,  KR
Applicant Contact Hye-Yeon Park
Correspondent
Mtech Group
8310 Buffalo Speedway
Houston,  TX  77025
Correspondent Contact Dave Kim
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received06/26/2017
Decision Date 08/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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