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510(k) K222124

Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 2022
Date Received
July 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

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