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

    FU HONG INDUSTRIES LIMITED SOOTHER TEETHER

    K Number: K093370 · Decision Jan 21, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    84

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    Basic Information

    Device Name
    FU HONG INDUSTRIES LIMITED SOOTHER TEETHER
    K Number
    K093370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5550
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fu Hong Industries , Ltd.
    Date Received
    October 29, 2009
    Decision Date
    January 21, 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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    Other Clearances by Fu Hong Industries , Ltd.

    K Number Device Name
    K052531 FU HONG INDUSTRIES LIMITED SOOTHER TEETHER