U&U Blood Collection Sets

Needle, Hypodermic, Single Lumen

U&U Medical Technology Co.,Ltd

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.

Pre-market Notification Details

Device IDK181508
510k NumberK181508
Device Name:U&U Blood Collection Sets
ClassificationNeedle, Hypodermic, Single Lumen
Applicant U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou,  CN 213119
ContactNick Wang
CorrespondentNick Wang
U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou,  CN 213119
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-07
Decision Date2019-02-13
Summary:summary

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