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    K Number
    K012830
    Device Name
    LERMAN & SON CRANIAL ORTHOSIS HELMET
    Manufacturer
    LERMAN & SON
    Date Cleared
    2001-11-20

    (89 days)

    Product Code
    MVA
    Regulation Number
    882.5970
    Why did this record match?
    Applicant Name (Manufacturer) :

    **LERMAN **& SON

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a physician for treatment of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).
    Device Description
    The Lerman & Son Cranial Orthosis Helmet is a custom made orthosis used to treat children between the ages of three and eighteen months for abnormal head shapes. Through the concavity formed during the design of this helmet, the skull is encouraged to grow in a more normal manner.
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