DR Safety Syringe, Sterile Hypodermic Needle For Single Use

Syringe, Antistick

Zhuhai DR Medical Instruments Co., Ltd

The following data is part of a premarket notification filed by Zhuhai Dr Medical Instruments Co., Ltd with the FDA for Dr Safety Syringe, Sterile Hypodermic Needle For Single Use.

Pre-market Notification Details

Device IDK212226
510k NumberK212226
Device Name:DR Safety Syringe, Sterile Hypodermic Needle For Single Use
ClassificationSyringe, Antistick
Applicant Zhuhai DR Medical Instruments Co., Ltd Floor 4, Factory Building A, No.288, East Airport Road, Jinwan District Zhuhai,  CN
ContactXu Jianhai
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMEG  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-07-16
Decision Date2021-09-29

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