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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K242134
Device Name ClearCap Distal Attachment
Applicant
Finemedix Co., Ltd.
140-9, Yuram-Ro, Dong-Gu
Daegu,  KR 41059
Applicant Contact Seok-Jun Ma
Correspondent
Finemedix Co., Ltd.
140-9, Yuram-Ro, Dong-Gu
Daegu,  KR 41059
Correspondent Contact Seok-Jun Ma
Regulation Number876.1500
Classification Product Code
OCX  
Date Received07/22/2024
Decision Date 08/20/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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