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.
|Device Name:||Oral/Enteral Syringe With ENFit Connector|
|Classification||Enteral Syringes With Enteral Specific Connectors|
|Applicant||Ningbo Tianyi Medical Appliance Co., Ltd. No.788, Mozhi North Road, Tourism Resort, Dongqian Lake Ningbo, CN 315121|
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120
|CFR Regulation Number||876.5980 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|