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 |