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510(k) Data Aggregation

    K Number
    K011433
    Device Name
    BALLERT CRANIAL MOLDING HELMET
    Manufacturer
    GEMA, INC.
    Date Cleared
    2001-06-12

    (33 days)

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

    GEMA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ballert Cranial Molding Helmet is intended for use by or under the direction of a physician for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-and brachycephalic-shaped heads.
    Device Description
    Not Found
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