U&U Indicator Tape And Strip

Indicator, Physical/chemical Sterilization Process

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 Indicator Tape And Strip.

Pre-market Notification Details

Device IDK171823
510k NumberK171823
Device Name:U&U Indicator Tape And Strip
ClassificationIndicator, Physical/chemical Sterilization Process
Applicant U&U Medical Technology Co., Ltd Dongzhou Village Hengshanqiao Changzhou,  CN 213119
ContactXuebo Wang
CorrespondentXuebo Wang
U&U Medical Technology Co., Ltd Dongzhou Village Hengshanqiao Changzhou,  CN 213119
Product CodeJOJ  
CFR Regulation Number880.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-19
Decision Date2018-02-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
D7966127 K171823 000
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10889950002268 K171823 000
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10889950002350 K171823 000
10889950002398 K171823 000
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10889950002411 K171823 000
D7966125 K171823 000
D79661250 K171823 000
D796612 K171823 000
D79661290 K171823 000
D79661270 K171823 000
D89260705600591 K171823 000
D89260705600581 K171823 000
D89260705600571 K171823 000
10889950002466 K171823 000
10889950002459 K171823 000
10889950002442 K171823 000
10889950002435 K171823 000
10889950002428 K171823 000
D930321130030 K171823 000

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