510(k) K220060

Device
Pre-filled Syringe With Saline
Applicant
Jiangsu Caina Medical Co., Ltd.
510(k) number
K220060
Product code
NGT  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-10
Date received
2022-01-10
Regulation
880.5200
Classification name
Saline, Vascular Access Flush
Medical specialty
General Hospital
Review panel
General Hospital
Clearance type
Traditional
Third party reviewed
No

Legacy Summary#

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FDA Review#

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