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    K Number
    K123855
    Device Name
    WATER-FILLED TEETHER
    Manufacturer
    SOLID TOYS IND. LTD.
    Date Cleared
    2013-05-24

    (161 days)

    Product Code
    KKO
    Regulation Number
    872.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOLID TOYS IND. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indicated to soothe and cool teething babies and help reduce teething pain.
    Device Description
    The proposed Water-filled teether is a simple plastic shaped device which is filled with water. It may be placed in a refrigerator to be cooled and then provided to the teething baby to help sooth any pain from teething. This is an OTC device.
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