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510(k) Data Aggregation

    K Number
    K955749
    Device Name
    TEX-CARE STERILE STOCKINETTE
    Manufacturer
    Date Cleared
    1996-11-22

    (339 days)

    Product Code
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLYNT AMTEX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sterile stockinette is used primarily as an surgical extremity drape to establish a sterile field. Bias cut sterile stockinette is used as a dressing retainer where swelling is expected.
    Device Description
    Sterile stockinette includes single and double ply rolls, bias cut rolls and impervious stockinette in various widths and lengths.
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