Syringe With Safety Needle, Safety Needle

Syringe, Piston

Jiangsu Caina Medical Co., Ltd

The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd with the FDA for Syringe With Safety Needle, Safety Needle.

Pre-market Notification Details

Device IDK193526
510k NumberK193526
Device Name:Syringe With Safety Needle, Safety Needle
ClassificationSyringe, Piston
Applicant Jiangsu Caina Medical Co., Ltd No.23,Huanxi Rd. Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeFMF  
Subsequent Product CodeFMI
Subsequent Product CodeMEG
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-19
Decision Date2020-07-17

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