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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K231267
Device Name ClearTip
Applicant
Finemedix Co., Ltd.
140-9, Yuram-Ro, Dong-Gu
Daegu,  KR 41059
Applicant Contact Seok-Jun Ma
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number876.1075
Classification Product Code
FCG  
Date Received05/02/2023
Decision Date 06/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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