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510(k) K212857

Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use by Jiangsu Zhiyu Medical Instrument Co, Ltd. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2023
Date Received
September 8, 2021
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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