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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope Accessory
510(k) Number K251478
Device Name ClearTip TBNA Type
Applicant
Finemedix Co., Ltd.
140-9, Yuram-Ro, Dong-Gu
Daegu,  KR
Applicant Contact Young-Hun Do
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman, Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number874.4680
Classification Product Code
KTI  
Date Received05/13/2025
Decision Date 04/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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