Sterile Syringe For Single Use With/without Needle

Syringe, Piston

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 Syringe For Single Use With/without Needle.

Pre-market Notification Details

Device IDK210227
510k NumberK210227
Device Name:Sterile Syringe For Single Use With/without Needle
ClassificationSyringe, Piston
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 CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-28
Decision Date2021-09-10

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