The following data is part of a premarket notification filed by Shantou Wealy Medical Instrument Co., Ltd. with the FDA for Enfit Reusable Enteral Syringe.
| Device ID | K203613 |
| 510k Number | K203613 |
| Device Name: | ENFit Reusable Enteral Syringe |
| Classification | Enteral Syringes With Enteral Specific Connectors |
| Applicant | Shantou Wealy Medical Instrument Co., Ltd. North Jinhuan Road (near Qishan Mid-school), Shantou China Shantou, CN 515064 |
| Contact | Yang Songling |
| Correspondent | Eva Li Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, CN 200122 |
| Product Code | PNR |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-10 |
| Decision Date | 2021-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971603585239 | K203613 | 000 |