Single Use O-ring Gasket Syringe With ENFit Connector, Reusable O-ring Gasket Syringe With ENFit Connector

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 Single Use O-ring Gasket Syringe With Enfit Connector, Reusable O-ring Gasket Syringe With Enfit Connector.

Pre-market Notification Details

Device IDK222155
510k NumberK222155
Device Name:Single Use O-ring Gasket Syringe With ENFit Connector, Reusable O-ring Gasket Syringe With ENFit Connector
ClassificationEnteral Syringes With Enteral Specific Connectors
Applicant Jiangsu Caina Medical Co., Ltd. No. 23, Huanxi Rd. Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentJianwei Pan
Jiangsu Caina Medical Co., Ltd. No. 23, Huanxi Rd. Zhutang Town Jiangyin,  CN 214415
Product CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-20
Decision Date2022-09-16

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