Oral/Enteral Syringe With ENFit Connector

Enteral Syringes With Enteral Specific Connectors

Ningbo Tianyi Medical Appliance Co., Ltd.

The following data is part of a premarket notification filed by Ningbo Tianyi Medical Appliance Co., Ltd. with the FDA for Oral/enteral Syringe With Enfit Connector.

Pre-market Notification Details

Device IDK211025
510k NumberK211025
Device Name:Oral/Enteral Syringe With ENFit Connector
ClassificationEnteral Syringes With Enteral Specific Connectors
Applicant Ningbo Tianyi Medical Appliance Co., Ltd. No.788, Mozhi North Road, Tourism Resort, Dongqian Lake Ningbo,  CN 315121
ContactWenyu Zhang
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-06
Decision Date2021-06-30

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