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510(k) K113587

AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE) by Shantou Wealy Medical Instrument Co.,Ltd — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2012
Date Received
December 5, 2011
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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