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510(k) Data Aggregation

    K Number
    K081476
    Device Name
    SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE
    Manufacturer
    SURGICAL CONCEPT DESIGNS
    Date Cleared
    2008-08-08

    (73 days)

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

    SURGICAL CONCEPT DESIGNS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Concept Designs Surgical Drape, Model #01001 is used to cover medical equipment in a surgical setting. It is to be used in general surgery.
    Device Description
    The Surgical Concept Designs Surgical Drape is a generally tubular sleeve of polyethylene film with an integrated equipment attachment feature at one end made from polycarbonate, with stainless steel pegs and a butyl rubber gasket.
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