The following data is part of a premarket notification filed by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. with the FDA for Safety Blood Collection Needles With/without Needle Holder.
| Device ID | K220900 |
| 510k Number | K220900 |
| Device Name: | Safety Blood Collection Needles With/without Needle Holder |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No.2 Guanyin Road, Taihu Economic Development Zone, Anqing City, Anhui Province Anqing, CN 246400 |
| Contact | Bingyi Xiang |
| Correspondent | Evan Hu Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, CN 201114 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-28 |
| Decision Date | 2022-08-10 |