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

    BURN BATH

    K Number: K841397 · Decision May 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    72
    Applicant Total
    7
    Review Days
    45

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    Basic Information

    Device Name
    BURN BATH
    K Number
    K841397
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Setma, Inc.
    Date Received
    April 3, 1984
    Decision Date
    May 18, 1984
    Product Code
    ILJ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILJ Bath, Hydro-Massage

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