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

    SHOE COVER

    K Number: K972227 · Decision Sep 9, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    291
    Registration Numbers
    291
    Same Product Code
    31
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    SHOE COVER
    K Number
    K972227
    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
    American Seal Co.
    Date Received
    June 13, 1997
    Decision Date
    September 9, 1997
    Product Code
    FYF
    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
    FYF Cap, Surgical

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