Pre-filled Syringe With Saline

Saline, Vascular Access Flush

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 Pre-filled Syringe With Saline.

Pre-market Notification Details

Device IDK220060
510k NumberK220060
Device Name:Pre-filled Syringe With Saline
ClassificationSaline, Vascular Access Flush
Applicant Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeNGT  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-10
Decision Date2022-06-10

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