510(k) K251411

Chemfort Female Luer Lock Adaptor by Simplivia Healthcare , Ltd. — Product Code ONB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 5, 2025
Date Received: May 7, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class: Class II
Regulation Number: 880.5440
Review Panel: HO
Submission Type

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

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