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510(k) K234024

HWJECT Auto-disable syringe by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2024
Date Received
December 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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