DISPOSABLE INJECTION NEEDLE

Endoscopic Injection Needle, Gastroenterology-urology

WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED

The following data is part of a premarket notification filed by Wilson Instruments (shanghai) Company Limited with the FDA for Disposable Injection Needle.

Pre-market Notification Details

Device IDK142144
510k NumberK142144
Device Name:DISPOSABLE INJECTION NEEDLE
ClassificationEndoscopic Injection Needle, Gastroenterology-urology
Applicant WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED BLDG 5, NO. 258 SHUANGBANG ROAD XUJING TOWN QINGPU DISTRICT Shang Hai,  CN 201702
ContactLijuan Zhang
CorrespondentLijuan Zhang
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED BLDG 5, NO. 258 SHUANGBANG ROAD XUJING TOWN QINGPU DISTRICT Shang Hai,  CN 201702
Product CodeFBK  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-05
Decision Date2015-01-15
Summary:summary

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