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510(k) K232475

Disposable infusion set with needle by Shandong Zhushi Pharmaceutical Group Co., Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2024
Date Received
August 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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