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 |