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510(k) Data Aggregation

    K Number
    K051300
    Device Name
    ROBIN HOOD VEST
    Manufacturer
    KAMBER CORPORATION
    Date Cleared
    2005-12-08

    (204 days)

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

    KAMBER CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Robin Hood Vest ™ is intended for use in healthy infants aged 0-15 months to aid in the prevention of skull deformities that can arise from consistent back-sleeping postures, the condition known as deformational (or positional) plagiocephaly.
    Device Description
    The Robin Hood Vest ™ is a sleeveless vest, with a pocket on the back for an insertable foam wedge, that an infant wears while sleeping. The device positions a foam wedge under the infant during sleep to direct the head so that it does not always rest on the same spot.
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