The following data is part of a premarket notification filed by Shinva Ande Healthcare Apparatus Co., Ltd. with the FDA for Disposable Enteral Feeding Syringe With Enfit Connector.
| Device ID | K193657 |
| 510k Number | K193657 |
| Device Name: | Disposable Enteral Feeding Syringe With Enfit Connector |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | Shinva Ande Healthcare Apparatus Co., Ltd. No.77 Development Zone North Road Zibo, CN 255086 |
| Contact | Xiaolei Tian |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Quinglan Street, Panyu District Guangzhou, CN 510006 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2020-09-12 |