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510(k) Data Aggregation

    K Number
    K071225
    Device Name
    INNOVASA STAT*SEAL TOPICAL HEMOSTAT
    Manufacturer
    INNOVASA, INC.
    Date Cleared
    2007-08-31

    (121 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVASA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Stat-Seal is indicated for use following femoral vascular catheterization procedures to assist in obtaining hemostasis.
    Device Description
    Trade Name, Stat*Seal Topical Hemostat
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