Sterile Safety Syringes For Single Use

Syringe, Antistick

Shanghai Kindly Enterprise Development Group Co., Ltd

The following data is part of a premarket notification filed by Shanghai Kindly Enterprise Development Group Co., Ltd with the FDA for Sterile Safety Syringes For Single Use.

Pre-market Notification Details

Device IDK221416
510k NumberK221416
Device Name:Sterile Safety Syringes For Single Use
ClassificationSyringe, Antistick
Applicant Shanghai Kindly Enterprise Development Group Co., Ltd No. 658 Gaochao Road Shanghai,  CN 201803
ContactLiu Hualong
CorrespondentEvan Hu
Shanghai Mind-Link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai,  CN 200040
Product CodeMEG  
Subsequent Product CodeFMF
Subsequent Product CodeFMI
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-16
Decision Date2022-08-31

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