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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Nephrostomy
510(k) Number K222705
Device Name Introducer Needle
Applicant
Youcare Technology Co.,Ltd. (Wuhan)
Great Wall Science And Technology Park
East Lake Development Zone, Wuhan
Wuhan,  CN
Applicant Contact Bing Hu
Correspondent
Youcare Technology Co.,Ltd. (Wuhan)
Great Wall Science And Technology Park
East Lake Development Zone, Wuhan
Wuhan,  CN
Correspondent Contact Bing Hu
Classification Product Code
LJE  
Date Received09/07/2022
Decision Date 05/22/2023
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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