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    K Number
    K080032
    Device Name
    ENVOYCEM, MODEL 1640
    Manufacturer
    ENVOY MEDICAL CORPORATION
    Date Cleared
    2008-02-28

    (52 days)

    Product Code
    NEA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENVOY MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EnvoyCem is intended for use in otologic surgery for the following applications: - Augmentation or coupling of the middle ear ossicles. - Attachment of the middle ear ossicles to middle ear implants. - Mechanical stabilization of middle ear prostheses.
    Device Description
    EnvoyCem is glass ionomer cement that is provided as two components, a glass powder and polyalkenoic acid liquid. By mixing the two components, viscous moldable ionomeric cement is obtained which hardens in situ.
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