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510(k) Data Aggregation

    K Number
    K983450
    Device Name
    STARRYSHINE GAUZE SPONGE
    Manufacturer
    T.C. DENTAL PRODUCTS, INC.
    Date Cleared
    1998-11-12

    (43 days)

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

    T.C. DENTAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    STARRYSHINE Gauze Sponges are intended for use to control bleeding, absorb body fluid, and protect wounds from contamination
    Device Description
    STARRYSHINE GAUZE SPONGE Are composed of USP type VII gauze, available in the thickness of 8 ply (2" x 2") 4 ply (2" x 2"), it's non-sterile and made with 100% cotton.use in control bleeding, absorb body fluids and protect wounds from contamination.
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