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510(k) K193022

Device
Retractable Safety Insulin Syringe
Applicant
Jiangsu Caina Medical Co.,Ltd
510(k) number
K193022
Product code
MEG
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-20
Date received
2019-10-30
Regulation
880.5860
Classification name
Syringe, Antistick
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Xinyan Ruan
Address
#23, Huanxi Rd., Zhutang Town Jiangyin CN 214425 214425

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MEG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K221073Sterile Hypodermic Syringes for Single Use with Safety NeedlesSichuan Prius Biotechnology Co., Ltd.2022-10-04
K220061Safety Insulin SyringesBerpu Medical Technology Co., Ltd.2022-08-23
K212518Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd.2022-08-18
K213077Automatically Retractable Safety SyringeZhejiang Lingyang Medical Apparatus Co., Ltd.2022-04-27