The following data is part of a premarket notification filed by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. with the FDA for Ldv((low Dead Volume )syringe.
| Device ID | K220083 |
| 510k Number | K220083 |
| Device Name: | LDV((Low Dead Volume )Syringe |
| Classification | Low Dead Space Piston Syringe |
| Applicant | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road, Taihu Economic Development Zone Anqing, CN 246400 |
| Contact | Bingyi Xiang |
| Correspondent | Evan Hu Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, CN 201114 |
| Product Code | QNQ |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-10 |
| Decision Date | 2022-05-25 |