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510(k) Data Aggregation

    K Number
    K130097
    Device Name
    MEDMATE TRANSFER ADAPTER AM5500 & AM5500-NS
    Manufacturer
    AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED
    Date Cleared
    2014-07-22

    (553 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedMate™ Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules. The device features a shield that prevents accidental needle sticks. The MedMate Guarded Needle is compatible for use with standard luer-slip and luer-lock syringes.
    Device Description
    Advanced Medical Innovations Guarded (18g) Needle is used for general purpose injection and aspiration of fluid from vials and ampoules.
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