BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SURGICAL GOWN

    K Number: K912790 · Decision Sep 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    86

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    Basic Information

    Device Name
    SURGICAL GOWN
    K Number
    K912790
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unicor Federal Dept. of Justice
    Date Received
    June 25, 1991
    Decision Date
    September 19, 1991
    Product Code
    FYE
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FYE Dress, Surgical

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