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510(k) Data Aggregation

    K Number
    K062261
    Device Name
    FOAM RING PORT PROTECTOR
    Date Cleared
    2007-04-09

    (248 days)

    Product Code
    Regulation Number
    880.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSPIRED IDEAS, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The foam ring, with the hole in the center, may be used in conjunction with ports (e.g., chemotherapy, vascular, etc.), up to 1 3/8" (3.5 cm) in diameter and raising less than 3/8" above the skin. The device is intended to cushion the localized area surrounding the port.
    Device Description
    The thickness of the foam ring, along with the hole in the center of the ring, aids in preventing things, such as seat belts, bra straps, and clothing, from rubbing against the embedded port. The product consists of one element; an off-white colored flat ring made out of non-latex hypoallergenic foam, with a die cut hole in the middle, with non-latex adhesive backing.
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