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    K Number
    K090284
    Device Name
    RES-Q INFANT WEDGE AND SLING
    Manufacturer
    CR ENTERPRISES, LLC.
    Date Cleared
    2009-06-05

    (120 days)

    Product Code
    FRP
    Regulation Number
    880.5680
    Why did this record match?
    Applicant Name (Manufacturer) :

    CR ENTERPRISES, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RES-Q Infant Wedge & Sling is designed to allow babies 0-12 months with gastroesophageal reflux to rest comfortably in a semi-upright position; it is used for sleeping and playtime in supine, prone, and side-lying positions.
    Device Description
    Device Name: RES-Q Infant Wedge & Sling Classification/Common Name: Holder, Infant Positioner Code FRP, CFR 880.5680 Class 1
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