The following data is part of a premarket notification filed by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd with the FDA for Sterile Hypodermic Syringe With/without Needle, Hypodermic Needle.
| Device ID | K222124 |
| 510k Number | K222124 |
| Device Name: | Sterile Hypodermic Syringe With/without Needle, Hypodermic Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd No. 2 Guanyin Road, Economic Development Zone, Taihu Anqing City, CN 246400 |
| Contact | Bingyi Xiang |
| Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-11-04 |