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510(k) Data Aggregation

    K Number
    K163529
    Device Name
    ReliaTect Post-Op Dressing with CHG (8cm x 15cm), ReliaTect Post-Op Dressing with CHG (10cm x 25cm)
    Manufacturer
    AVERY DENNISON CORPORATION
    Date Cleared
    2017-03-29

    (103 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    AVERY DENNISON CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ReliaTect™ Post-Op Dressing with CHG is intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures, and wires. ReliaTect™ may also be used to cover and secure a primary dressing. ReliaTect™ inhibits microbial growth within the dressing and prevents external contamination.
    Device Description
    The ReliaTect™ Post-Op Dressing with CHG is a transparent adhesive dressing integrated with Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad-spectrum antimicrobial activity.
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