Sterile Safety Syringe With Needle For Single Use, Sterile Safety Hypodermic Needle For Single Use,Sterile Auto-Disable Syringe With Needle For Single Use

Syringe, Piston

Shandong Weigao Group Medical Polymer Co., Ltd.

The following data is part of a premarket notification filed by Shandong Weigao Group Medical Polymer Co., Ltd. with the FDA for Sterile Safety Syringe With Needle For Single Use, Sterile Safety Hypodermic Needle For Single Use,sterile Auto-disable Syringe With Needle For Single Use.

Pre-market Notification Details

Device IDK212920
510k NumberK212920
Device Name:Sterile Safety Syringe With Needle For Single Use, Sterile Safety Hypodermic Needle For Single Use,Sterile Auto-Disable Syringe With Needle For Single Use
ClassificationSyringe, Piston
Applicant Shandong Weigao Group Medical Polymer Co., Ltd. No.18 Xingshan Road, Torch Hi-tech Science Park Weihai,  CN 264210
ContactLina Liu
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O.BOX 120-119 Shanghai,  CN 200120
Product CodeFMF  
Subsequent Product CodeFMI
Subsequent Product CodeMEG
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-14
Decision Date2022-03-11

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