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510(k) Data Aggregation

    K Number
    K070694
    Device Name
    CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
    Manufacturer
    Date Cleared
    2007-09-10

    (181 days)

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

    MIKE MINER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Craniocephalic Custom Remolding Orthosis (CCRO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.
    Device Description
    The CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape during natural infant growth. Appropriate for infants 3 to 18 months, the CCRO consists of a polypropylene (or copolymer, or polyethylene as warranted), outer shell with multiple inner polypropylene foam liners of various thicknesses, and an optional support strap. The foam liners and outer plastic shell, are vacuum formed over a positive mold developed from an impression of the infant's head. The orthosis allows applicable areas for the infant heads fill in during normal infant growth, to achieve appropriate cranial symmetry.
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