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510(k) K251442

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) by Ningbo Tianyi Medical Appliance Co., Ltd. — Product Code FJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2025
Date Received
May 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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