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510(k) K220060

Pre-filled Syringe with Saline by Jiangsu Caina Medical Co.,Ltd — Product Code NGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2022
Date Received
January 10, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Saline, Vascular Access Flush
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

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