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 ID | K211025 |
| 510k Number | K211025 |
| 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 |
| Contact | Wenyu Zhang |
| Correspondent | Diana Hong Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-06 |
| Decision Date | 2021-06-30 |