Sterile Hypodermic Safety Syringes For Single Use

Syringe, Antistick

JiangXi HongDa Medical Equipment Group Ltd.

The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Sterile Hypodermic Safety Syringes For Single Use.

Pre-market Notification Details

Device IDK163162
510k NumberK163162
Device Name:Sterile Hypodermic Safety Syringes For Single Use
ClassificationSyringe, Antistick
Applicant JiangXi HongDa Medical Equipment Group Ltd. No. 39 South Shengli Road, Jinxian County Nanchang,  CN 331700
ContactYang Xiaohua
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-10
Decision Date2017-03-20
Summary:summary

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