U&U Sterilization Pouch And Roll

Wrap, Sterilization

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 Sterilization Pouch And Roll.

Pre-market Notification Details

Device IDK143637
510k NumberK143637
Device Name:U&U Sterilization Pouch And Roll
ClassificationWrap, Sterilization
Applicant U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou,jiangshu,  CN 213119
ContactGarfield Wang
CorrespondentGarfield Wang
U&U Medical Technology Co.,Ltd Dongzhou Village, Hengshanqiao Changzhou,jiangshu,  CN 213119
Product CodeFRG  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-22
Decision Date2015-09-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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