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510(k) Data Aggregation

    K Number
    K252033
    Device Name
    Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
    Manufacturer
    CMT HEALTH PTE. LTD.
    Date Cleared
    2025-07-25

    (25 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMT HEALTH PTE. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K251585
    Device Name
    Profoject™ Enteral Feeding Syringe
    Manufacturer
    CMT Health PTE. Ltd.
    Date Cleared
    2025-07-18

    (56 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    CMT Health PTE. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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