U&U STERILE HYPODERMIC NEEDLE

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 Sterile Hypodermic Needle.

Pre-market Notification Details

Device IDK132552
510k NumberK132552
Device Name:U&U STERILE HYPODERMIC NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant U&U MEDICAL TECHNOLOGY CO., LTD DONGZHOU VILLAGE, HENGSHANQIAO Changzhou, Jiangsu,  CN 213119
ContactXuebo Wang
CorrespondentXuebo Wang
U&U MEDICAL TECHNOLOGY CO., LTD DONGZHOU VILLAGE, HENGSHANQIAO Changzhou, Jiangsu,  CN 213119
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-14
Decision Date2013-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
G002011070 K132552 000

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