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510(k) K210216

Disposable Automatically Retractable Insulin Safety Syringe by Shantou Wealy Medical Instrument Co.,Ltd — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2022
Date Received
January 27, 2021
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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  • K113587 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) (February 24, 2012)

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