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

    WINTER HEAD DRESSING

    K Number: K801458 · Decision Jul 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    681
    Registration Numbers
    681
    Same Product Code
    41
    Applicant Total
    6
    Review Days
    34

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    Basic Information

    Device Name
    WINTER HEAD DRESSING
    K Number
    K801458
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5075
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Steridyne Corp.
    Date Received
    June 24, 1980
    Decision Date
    July 28, 1980
    Product Code
    FQM
    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
    FQM Bandage, Elastic

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    K821314 FEVER METER