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510(k) Data Aggregation

    K Number
    K960219
    Device Name
    PROLEX MESH
    Date Cleared
    1996-03-15

    (59 days)

    Product Code
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED SURGICAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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