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510(k) K252098

PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) by Methyl Co., Ltd. — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2026
Date Received
July 3, 2025
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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