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510(k) K250733

3DOSE 1ml Syringe by Bimed Teknik Aletler Sanayi & Ticaret A.S. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
March 11, 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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