The following data is part of a premarket notification filed by Jiangsu Micsafe Medical Technology Co., Ltd. with the FDA for Safety Needles, Sterile Syringe, Sterile Syringe With Safety Needle, Sterile Syringe With Needle, Hypodermic Needle For Single Use.
| Device ID | K183665 |
| 510k Number | K183665 |
| Device Name: | Safety Needles, Sterile Syringe, Sterile Syringe With Safety Needle, Sterile Syringe With Needle, Hypodermic Needle For Single Use |
| Classification | Syringe, Antistick |
| Applicant | Jiangsu Micsafe Medical Technology Co., Ltd. Xituan Industrial Park, Dafeng District Yancheng, CN 224125 |
| Contact | Tony Yang |
| Correspondent | Tony Yang Jiangsu Micsafe Medical Technology Co., Ltd. Xituan Industrial Park, Dafeng District Yancheng, CN 224125 |
| 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 | 2018-12-27 |
| Decision Date | 2019-09-06 |
| Summary: | summary |