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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, NO. 258 SHUANGBANG ROAD
XUJING TOWN QINGPU DISTRICT
SHANG HAI,  CN 201702
Applicant Contact LIJUAN ZHANG
Correspondent
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED
BLDG 5, NO. 258 SHUANGBANG ROAD
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
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