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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K181690
Device Name Clear-Jet Injection Catheter
Finemedix Co. Ltd.
60, Maeyeo-ro, Dong-gu
Daegu,  KR 41065
Applicant Contact Hee Kyung Kwon
Withus Group Inc
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number876.1500
Classification Product Code
Date Received06/26/2018
Decision Date 12/21/2018
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