Pump Alignment Syringe

Syringe, Piston

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 Pump Alignment Syringe.

Pre-market Notification Details

Device IDK220184
510k NumberK220184
Device Name:Pump Alignment Syringe
ClassificationSyringe, Piston
Applicant Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentJianwei Pan
Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin,  CN 214415
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-24
Decision Date2022-07-21

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