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    K Number
    K062143
    Device Name
    KOZY COMFORT INFANT POSITIONER
    Manufacturer
    ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING
    Date Cleared
    2006-10-24

    (89 days)

    Product Code
    FRP
    Regulation Number
    880.5680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly
    Device Description
    Kozy Comfort™ Infant Positioner is a polyurethane based infant positioner.
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