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    K Number
    K042495
    Device Name
    CUMULASE
    Manufacturer
    HALOZYME THERAPEUTICS INC.
    Date Cleared
    2005-04-14

    (212 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    HALOZYME THERAPEUTICS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cumulase™ is indicated for use in removing the cumulus matrix surrounding oocytes in preparation for assisted reproduction technology (ART) procedures.
    Device Description
    Recombinant Human Hyaluronidase Solution Cumulase™ is a hyaluronidase enzyme in a HEPES buffered salt solution. The hyaluronidase enzyme raw material is a highly characterized biotechnology developed recombinant human hyaluronidase (rHuPH20). Cumulase™ is not preserved.
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