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510(k) Data Aggregation

    K Number
    K962972
    Device Name
    SURGICADE GAUZE SPONGE
    Date Cleared
    1996-10-11

    (72 days)

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

    ACCUNEX CANADA,INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Control bleeding, absorb body fluids, and protect wounds from contamination.
    Device Description
    Surgicade™ Non-Sterile Gauze Sponges are composed of USP Type VII gauze, ourgical on the each Spire Care Spirity and Compose of Carrype of Suble available in thicknesses of 8 ply (2" x 2", 4" x 4", 4" x 8"), 12 ply (2" x 2", 3" x 3", 4" x 4", 4"
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