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

    GEL FILLED GUM SOOTHER

    K Number: K092494 · Decision Mar 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    199

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    Basic Information

    Device Name
    GEL FILLED GUM SOOTHER
    K Number
    K092494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5550
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Luv N' Care, Ltd.
    Date Received
    August 14, 2009
    Decision Date
    March 1, 2010
    Product Code
    KKO
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KKO Ring, Teething, Fluid-Filled

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