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

    FUNGUS FIGHTER INSOLES

    K Number: K780719 · Decision Oct 10, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    0
    Applicant Total
    6
    Review Days
    162

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    Basic Information

    Device Name
    FUNGUS FIGHTER INSOLES
    K Number
    K780719
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6280
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Combe, Inc.
    Date Received
    May 1, 1978
    Decision Date
    October 10, 1978
    Product Code
    KYS
    Advisory Committee
    General Hospital
    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
    KYS Insoles, Medical

    Other Clearances by Combe, Inc.

    K Number Device Name
    K942203 OTC DENTURE CLEANSER
    K925259 CFR MONOGRAPH
    K863375 SEA-BOND
    K770413 CUSHIONS, DENTURE ADHESIVE, ALL-DAY
    K770175 SEA-BOND ADHEVISE DENTURE CUSHIONS