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

    REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)

    K Number: K093100 · Decision Nov 24, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    54

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    Basic Information

    Device Name
    REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA)
    K Number
    K093100
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5110
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Comfort Technology Co., Ltd.
    Date Received
    October 1, 2009
    Decision Date
    November 24, 2009
    Product Code
    IMC
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    IMC Bath, Paraffin

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