The following data is part of a premarket notification filed by U&u Medical Technology Co.,ltd with the FDA for U&u Blood Collection Sets.
| Device ID | K181508 |
| 510k Number | K181508 |
| Device Name: | U&U Blood Collection Sets |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou, CN 213119 |
| Contact | Nick Wang |
| Correspondent | Nick Wang U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou, CN 213119 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-07 |
| Decision Date | 2019-02-13 |
| Summary: | summary |