Safety Needles, Sterile Syringe, Sterile Syringe With Safety Needle, Sterile Syringe With Needle, Hypodermic Needle For Single Use

Syringe, Antistick

Jiangsu Micsafe Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Micsafe Medical Technology Co., Ltd. with the FDA for Safety Needles, Sterile Syringe, Sterile Syringe With Safety Needle, Sterile Syringe With Needle, Hypodermic Needle For Single Use.

Pre-market Notification Details

Device IDK183665
510k NumberK183665
Device Name:Safety Needles, Sterile Syringe, Sterile Syringe With Safety Needle, Sterile Syringe With Needle, Hypodermic Needle For Single Use
ClassificationSyringe, Antistick
Applicant Jiangsu Micsafe Medical Technology Co., Ltd. Xituan Industrial Park, Dafeng District Yancheng,  CN 224125
ContactTony Yang
CorrespondentTony Yang
Jiangsu Micsafe Medical Technology Co., Ltd. Xituan Industrial Park, Dafeng District Yancheng,  CN 224125
Product CodeMEG  
Subsequent Product CodeFMF
Subsequent Product CodeFMI
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-27
Decision Date2019-09-06
Summary:summary

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