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510(k) K252279

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) by Chirana T.Injecta,A.S. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2026
Date Received
July 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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