Disposable High Pressure Syringe

Injector And Syringe, Angiographic

Union Medical Shenzhen Co., Ltd.

The following data is part of a premarket notification filed by Union Medical Shenzhen Co., Ltd. with the FDA for Disposable High Pressure Syringe.

Pre-market Notification Details

Device IDK170279
510k NumberK170279
Device Name:Disposable High Pressure Syringe
ClassificationInjector And Syringe, Angiographic
Applicant Union Medical Shenzhen Co., Ltd. Room 603, Building 3, Fantasia MIC Plaza, Nanhai Avenue Nanshan District Shenzhen,  CN 518062
ContactWenguo Zhang
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-30
Decision Date2017-12-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06970286900438 K170279 000
10850014500211 K170279 000
10850014500204 K170279 000
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10850014500150 K170279 000
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10850014500136 K170279 000
10850014500129 K170279 000
10850014500112 K170279 000
20850014500096 K170279 000
10850014500075 K170279 000
10850014500051 K170279 000
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10850014500228 K170279 000
06970286900315 K170279 000
06970286900483 K170279 000
06970286900407 K170279 000
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06970286900421 K170279 000
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06970286900353 K170279 000
06970286900377 K170279 000
06970286900339 K170279 000
06970286900322 K170279 000
10850014500013 K170279 000

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