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510(k) Data Aggregation

    K Number
    K990288
    Device Name
    FREE FLOW SAFETY DEVICE, MODEL MG 245052
    Manufacturer
    Date Cleared
    1999-02-24

    (26 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEVA MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use with any I.V. set assembled on commercially available I.V. pumps (not equipped with free flow protection), in order to prevent free flow of drugs or I.V. fluids.
    Device Description
    Anti Free Flow Valve
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    K Number
    K974171
    Device Name
    COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
    Manufacturer
    Date Cleared
    1997-12-19

    (44 days)

    Product Code
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    TEVA MEDICAL, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Subcutaneous injection of Copaxone®.
    Device Description
    Not Found
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