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510(k) K190183

Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe by Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 2019
Date Received
February 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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