Blood Collection Needle With/without Holder, Safety Blood Collection Needle With/without Holder, Luer Access Device-holder With Preattached Multiple Sample Adapter

Tubes, Vials, Systems, Serum Separators, Blood Collection

Jiangsu Caina Medical Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Blood Collection Needle With/without Holder, Safety Blood Collection Needle With/without Holder, Luer Access Device-holder With Preattached Multiple Sample Adapter.

Pre-market Notification Details

Device IDK200027
510k NumberK200027
Device Name:Blood Collection Needle With/without Holder, Safety Blood Collection Needle With/without Holder, Luer Access Device-holder With Preattached Multiple Sample Adapter
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentDiana Hong
Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-06
Decision Date2020-09-09

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