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 Sets For Single Use.
| Device ID | K202188 |
| 510k Number | K202188 |
| Device Name: | Safety Blood Collection Sets For Single Use |
| 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 City, CN 246400 |
| Contact | Gang Yu |
| 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 | 2020-08-04 |
| Decision Date | 2021-02-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16958697602971 | K202188 | 000 |
| 16958697607228 | K202188 | 000 |
| 16958697607211 | K202188 | 000 |