1ml Luer Slip Or Luer Lock Syringe, Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle

Syringe, Antistick

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 1ml Luer Slip Or Luer Lock Syringe, Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle.

Pre-market Notification Details

Device IDK192551
510k NumberK192551
Device Name:1ml Luer Slip Or Luer Lock Syringe, Syringe With Permanently Attached Needle, Safety Syringe With Permanently Attached Needle
ClassificationSyringe, Antistick
Applicant Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin,  CN 214415
ContactXinyan Ruan
CorrespondentDiana Hong
Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai,  CN 200120
Product CodeMEG  
Subsequent Product CodeFMF
Subsequent Product CodeFMI
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-17
Decision Date2020-08-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
16971564465165 K192551 000
10850041572731 K192551 000
10850041572748 K192551 000
10850041572755 K192551 000
10850041572762 K192551 000
20193489099215 K192551 000
16971564466025 K192551 000
16971564465615 K192551 000
16971564465264 K192551 000
10850041572724 K192551 000

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