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 Needle (without Needle Holder).
| Device ID | K222141 |
| 510k Number | K222141 |
| Device Name: | Safety Blood Collection Needle (Without Needle Holder) |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road, Economic Development Zone, Taihu Anqing, CN 246400 |
| Contact | Bingyi Xiang |
| Correspondent | Charles Mack IRC 2950 E Lindrick Drive Chandler, AZ 85249 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-20 |
| Decision Date | 2022-10-21 |