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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 K142144
Device Name DISPOSABLE INJECTION NEEDLE
Applicant
Wilson Instruments (Shanghai) Company Limited
Bldg. 5, # 258 Shuangbang Rd.
Xujing Town Qingpu District
Shang Hai,  CN 201702
Applicant Contact LIJUAN ZHANG
Correspondent
Wilson Instruments (Shanghai) Company Limited
Bldg. 5, # 258 Shuangbang Rd.
Xujing Town Qingpu District
Shang Hai,  CN 201702
Correspondent Contact LIJUAN ZHANG
Regulation Number876.1500
Classification Product Code
FBK  
Date Received08/05/2014
Decision Date 01/15/2015
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
Predetermined Change
Control Plan Authorized		 No
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