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510(k) Data Aggregation

    K Number
    K980078
    Device Name
    PENETREASE
    Manufacturer
    P.T. PANCA PUSAKA DELI
    Date Cleared
    1998-10-16

    (281 days)

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

    P.T. PANCA PUSAKA DELI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A device intended for medical purposes used to inject fluids into, or withdraw fluids from, the body that consists of a calibrated hollow barrel and a movable plunger. At one end of barrel there is a needle.
    Device Description
    Not Found
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