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

    MAM COOLER

    K Number: K093266 · Decision Jul 27, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    26
    Applicant Total
    2
    Review Days
    281

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    Basic Information

    Device Name
    MAM COOLER
    K Number
    K093266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.5550
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mam International AG
    Date Received
    October 19, 2009
    Decision Date
    July 27, 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 Mam International AG

    K Number Device Name
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