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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, retention type, balloon
510(k) Number K172807
Device Name Silicone Foley Catheter for single use
Changzhou Rongxin Medicine Minimal Invasion Technology
No. 8, Jianerkang Road, Industrial Concentration Area,
Zhixi Town
Jintan City,  CN 213251
Applicant Contact Ping Liu
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
8-9Th Floor, R&D Building, No. 26 Qinglan Street
Panyu District
Guangzhou,  CN 510006
Correspondent Contact Mike Gu
Regulation Number876.5130
Classification Product Code
Date Received09/18/2017
Decision Date 06/04/2018
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