Sterile High-pressure Angiographic Syringes For Single-use

Injector And Syringe, Angiographic

Youwo (Guangzhou) Medical Device Co., Ltd.

The following data is part of a premarket notification filed by Youwo (guangzhou) Medical Device Co., Ltd. with the FDA for Sterile High-pressure Angiographic Syringes For Single-use.

Pre-market Notification Details

Device IDK201395
510k NumberK201395
Device Name:Sterile High-pressure Angiographic Syringes For Single-use
ClassificationInjector And Syringe, Angiographic
Applicant Youwo (Guangzhou) Medical Device Co., Ltd. Kaiyuan Avenue, High-Tech Industrial Development Zone Guangzhou,  CN 510530
ContactMeijin Song
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 Received2020-05-27
Decision Date2020-10-28

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