Enteral Pump Syringe

Enteral Syringes With Enteral Specific Connectors

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 Enteral Pump Syringe.

Pre-market Notification Details

Device IDK211593
510k NumberK211593
Device Name:Enteral Pump Syringe
ClassificationEnteral Syringes With Enteral Specific Connectors
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 CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-24
Decision Date2021-09-30

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