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510(k) Data Aggregation

    K Number
    K041996
    Device Name
    NIGHTFORM
    Date Cleared
    2004-08-03

    (8 days)

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

    PLASTIC SURGERY SOLUTIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NightForm product is indicated for healthy infants 0-9 months to aid in the prevention of skull deformities that can rise from consistent back-sleeping postures, known as Deformational (or positional) plagiocephaly.
    Device Description
    NightForm is a fabric-covered polyurethane foam mattress with two accompanying fabric-covered polyurethane wedges that affix to the mattress by hook/loop fasteners in various positions that permit parents to modify nightly the supine sleeping position of their sleeping infants and thereby prevent a condition known as deformational plagiocephaly.
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