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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 K173340
Device Name Yikang Latex Foley Catheter
Applicant
Jiangxi Yikang Medical Instrument Group Co., LTD.
No.188 LiduAihua Ave., Jinxian County
Nanchang,  CN 331725
Applicant Contact Nicholas Su
Correspondent
Jiangxi Yikang Medical Instrument Group Co., LTD.
No.188 LiduAihua Ave., Jinxian County
Nanchang,  CN 331725
Correspondent Contact Nicholas Su
Regulation Number876.5130
Classification Product Code
EZL  
Date Received10/23/2017
Decision Date 07/13/2018
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
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