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510(k) K222452

Disposable Automatically Retractable Safety Syringes (with detachable needle) by Shantou Wealy Medical Instrument Co.,Ltd — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2022
Date Received
August 15, 2022
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

Other clearances by Shantou Wealy Medical Instrument Co.,Ltd

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  • K141640 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE (November 19, 2014)
  • K113587 — AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) (February 24, 2012)

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