Blood Collection Needle For Single Use & Blood Collection Needle With Holder For Single Use, Safety Blood Collection Needle For Single Use, Safety Blood Collection Needle With Holder For Single Use, Blood Collection Set For Single Use & Safety Blood

Tubes, Vials, Systems, Serum Separators, Blood Collection

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 Blood Collection Needle For Single Use & Blood Collection Needle With Holder For Single Use, Safety Blood Collection Needle For Single Use, Safety Blood Collection Needle With Holder For Single Use, Blood Collection Set For Single Use & Safety Blood .

Pre-market Notification Details

Device IDK212019
510k NumberK212019
Device Name:Blood Collection Needle For Single Use & Blood Collection Needle With Holder For Single Use, Safety Blood Collection Needle For Single Use, Safety Blood Collection Needle With Holder For Single Use, Blood Collection Set For Single Use & Safety Blood
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
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 CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-28
Decision Date2021-11-04

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