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510(k) Data Aggregation

    K Number
    K013458
    Device Name
    CRANIAL HELMET
    Date Cleared
    2001-10-29

    (11 days)

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

    CHILDREN'S HOSPITAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Children's Hospital cranial helmet is intended to apply passive pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from three to eighteen months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
    Device Description
    The Children's Hospital cranial helmet is a cranial orthosis for the treatment of deformational plagiocephaly. It is a lightweight, semi-rigid plastic helmet with a foam lining. Each helmet is assembled individually, with some areas that fit snugly to the child's head, and with other recessed areas. As the child's brain grows, the skull is slowly reshaped and rounded by growing into the recessed areas.
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    K Number
    K003035
    Device Name
    CLARREN HELMET
    Date Cleared
    2001-06-06

    (251 days)

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

    CHILDREN'S HOSPITAL & MEDICAL CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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