Sterile Hypodermic Syringe With/without Needle, Hypodermic Needle

Needle, Hypodermic, Single Lumen

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 Sterile Hypodermic Syringe With/without Needle, Hypodermic Needle.

Pre-market Notification Details

Device IDK222124
510k NumberK222124
Device Name:Sterile Hypodermic Syringe With/without Needle, Hypodermic Needle
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd No. 2 Guanyin Road, Economic Development Zone, Taihu Anqing City,  CN 246400
ContactBingyi Xiang
CorrespondentCharles Mack
IRC 2950 E Lindrick Drive Chandler,  AZ  85249
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-18
Decision Date2022-11-04

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