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510(k) Data Aggregation

    K Number
    K103549
    Device Name
    DENOVO TEDDY GEL INFANT HEEL WARMER
    Manufacturer
    DENOVO PRODUCTS LLC
    Date Cleared
    2011-04-08

    (126 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENOVO PRODUCTS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use by hospital, Ambulatory Surgery staff, Outpatient Clinics for warming of Infant's Heels prior to drawing blood for sampling or general analysis. This device is intended for Rx use only. This device is single use, non-sterile, and disposable.
    Device Description
    Not Found
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