The following data is part of a premarket notification filed by Jiangxi Hongda Medical Equipment Group Ltd. with the FDA for Sterile Syringe With Safety Needle.
| Device ID | K211753 |
| 510k Number | K211753 |
| Device Name: | Sterile Syringe With Safety Needle |
| Classification | Syringe, Antistick |
| Applicant | Jiangxi Hongda Medical Equipment Group Ltd. No. 39 South Shengli Road Nanchang, CN 331700 |
| Contact | Xiaohua Yang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | MEG |
| Subsequent Product Code | FMF |
| Subsequent Product Code | FMI |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-07 |
| Decision Date | 2021-10-14 |