BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SURGICAL DRAPES

    K Number: K061422 · Decision Sep 25, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    449
    Applicant Total
    1
    Review Days
    125

    Basic Information

    Device Name
    SURGICAL DRAPES
    K Number
    K061422
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AUSTIN MEDICAL, INC.
    Date Received
    May 23, 2006
    Decision Date
    September 25, 2006
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKX Drape, Surgical

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