LDV((Low Dead Volume )Syringe

Low Dead Space Piston Syringe

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.

The following data is part of a premarket notification filed by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. with the FDA for Ldv((low Dead Volume )syringe.

Pre-market Notification Details

Device IDK220083
510k NumberK220083
Device Name:LDV((Low Dead Volume )Syringe
ClassificationLow Dead Space Piston Syringe
Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road, Taihu Economic Development Zone Anqing,  CN 246400
ContactBingyi Xiang
CorrespondentEvan Hu
Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai,  CN 201114
Product CodeQNQ  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-10
Decision Date2022-05-25

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