Disposable Sterile Syringe, Disposable Sterile Syringe With Needle

Syringe, Piston

Guangdong Antmed Co., Ltd.

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

Pre-market Notification Details

Device IDK210991
510k NumberK210991
Device Name:Disposable Sterile Syringe, Disposable Sterile Syringe With Needle
ClassificationSyringe, Piston
Applicant Guangdong Antmed Co., Ltd. Rm 201, Bld 3, Hualian Ave, Songshanhu District Dongguan,  CN 523800
ContactZhiying Zhong
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai,  CN 200120
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-02
Decision Date2021-08-26

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