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510(k) Data Aggregation

    K Number
    K060037
    Device Name
    FITPACK
    Date Cleared
    2006-07-25

    (200 days)

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

    ASP PLASTICS PTY LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fitpack® DS-128 and DS-130 Fit Tank Products are intended to be used for the collection, transportation and disposal of hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used hypodermic needles and syringes. The Fitpack® DS-047 Disposa Safe Clean Up, DS-091 Disposa Safe Products are intended to be used for the collection, transportation and disposal of 1 ml insulin hypodermic needles and syringes in health care arcas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml insulin hypodermic needles and syringes. The Fitpack® DS-046 mini fit tube Product is intended to be used for the collection, transportation and disposal of 1 ml and 2 ml hypodermic needles and syringes in health care areas, home care environment and any other area requiring the use of sharps containers for the collection, transportation and disposal of used 1 ml and 2 ml hypodermic needles and syringes.
    Device Description
    Not Found
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