Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle

Syringe, Antistick

Yangzhou Medline Industry Co., Ltd.

The following data is part of a premarket notification filed by Yangzhou Medline Industry Co., Ltd. with the FDA for Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle.

Pre-market Notification Details

Device IDK170651
510k NumberK170651
Device Name:Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
ClassificationSyringe, Antistick
Applicant Yangzhou Medline Industry Co., Ltd. No. 108, Jinshan Road, Economic Development Zone Yangzhou,  CN 225000
ContactJianzhong Qi
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeMEG  
Subsequent Product CodeFMF
Subsequent Product CodeFMI
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-03
Decision Date2017-08-02
Summary:summary

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