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510(k) Data Aggregation

    K Number
    K060986
    Device Name
    HEAD BED
    Manufacturer
    STEVEN H. WARNOCK, M.D.
    Date Cleared
    2006-07-11

    (92 days)

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

    STEVEN H. WARNOCK, M.D.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Head Bed™ infant positioner is indicated for infants aged 0-6 months to aid in the prevention of deformational plagiocephaly.
    Device Description
    The Head Bed device is a U-shaped soft polyurethane foam cushion covered in flame retardant cloth material. Outside dimensions are 17.5cm (w) x 18.5cm (1) x 4cm (h). Inside dimensions are 13.5cm (h) x 6.5cm (w). The device is adequately soft so as to provide support for the infants head without being abrasive. The removable cloth cover is flame retardant and machine washable.
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