The following data is part of a premarket notification filed by Henan Nursecare Biotechnology Co., Ltd with the FDA for Sterile Syringe With Safety Needle For Single Use, Sterile Syringe With Needle For Single Use, Sterile Syringe For Single Use, Sterile Safety Needle For Single Use, Sterile Needle For Single Use.
| Device ID | K212949 |
| 510k Number | K212949 |
| Device Name: | Sterile Syringe With Safety Needle For Single Use, Sterile Syringe With Needle For Single Use, Sterile Syringe For Single Use, Sterile Safety Needle For Single Use, Sterile Needle For Single Use |
| Classification | Syringe, Antistick |
| Applicant | Henan Nursecare Biotechnology Co., Ltd Building C1, Xindong Science Park, No. 299 Dongzhuo Road Xinxiang, CN 453700 |
| Contact | Yaping Zhang |
| Correspondent | Johnson Liu Cnmed Consultant 31 Archer St Upper Mt Gravatt, AU 4122 |
| Product Code | MEG |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-16 |
| Decision Date | 2022-02-24 |