The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd with the FDA for Nrfit Syringe.
| Device ID | K181374 |
| 510k Number | K181374 |
| Device Name: | NRFit Syringe |
| Classification | Piston Syringe With Neuraxial Connector - Epidural And Peripheral Delivery |
| Applicant | Jiangsu Caina Medical Co., Ltd No. 23, Huanxi Road, Zhutang Town Jiangyin, CN 214421 |
| Contact | Jun Lu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | QEH |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-24 |
| Decision Date | 2018-12-14 |
| Summary: | summary |