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510(k) K221981

SafeR Syringe and SafeR Sting by Roncadelle Operations Srl — Product Code MEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2022
Date Received
July 5, 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

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