Automatically Retractable Safety Syringe

Syringe, Antistick

Zhejiang Lingyang Medical Apparatus Co., Ltd.

The following data is part of a premarket notification filed by Zhejiang Lingyang Medical Apparatus Co., Ltd. with the FDA for Automatically Retractable Safety Syringe.

Pre-market Notification Details

Device IDK213077
510k NumberK213077
Device Name:Automatically Retractable Safety Syringe
ClassificationSyringe, Antistick
Applicant Zhejiang Lingyang Medical Apparatus Co., Ltd. Baishuiyang Town Linhai,  CN 317031
ContactWang Minjun
CorrespondentOlivia Meng
Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou,  CN 510006
Product CodeMEG  
Subsequent Product CodeFMF
Subsequent Product CodeFMI
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-23
Decision Date2022-04-27

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