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510(k) K230343

ProSeal™ Closed System Administration Set by Epic Medical Pte. , Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2023
Date Received
February 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
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  • K242763 — JetCan® Pro Safety Huber Needle (May 2, 2025)