Sterile Hypodermic Needles For Single Use

Needle, Hypodermic, Single Lumen

Zhejiang Kangkang Medical-Devices CO., Ltd.

The following data is part of a premarket notification filed by Zhejiang Kangkang Medical-devices Co., Ltd. with the FDA for Sterile Hypodermic Needles For Single Use.

Pre-market Notification Details

Device IDK210232
510k NumberK210232
Device Name:Sterile Hypodermic Needles For Single Use
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town Yuhuan,  CN 317605
ContactChun Guo
CorrespondentChun Guo
Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town Yuhuan,  CN 317605
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-28
Decision Date2021-09-23

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