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510(k) Data Aggregation

    K Number
    K101214
    Device Name
    GUARDIAN CONNECTION
    Manufacturer
    MAULIN MEDICAL LLC
    Date Cleared
    2010-07-23

    (84 days)

    Product Code
    FPD
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAULIN MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GUARDIAN CONNECTION™ is designed to be used with standard adult tapered feeding tube connectors to secure the connection.
    Device Description
    The Guardian Connection is a non-sterile, reusable, plastic "Ushaped" clip designed to hold the connectors of an enteric feeding tube and an enteric feeding set together to help prevent inadvertent disconnection. The product is specifically designed to accommodate the non-IV tapered male conical stepped connectors and mating non-IV tapered female connectors commonly found on standard adult enteric feeding tubes and sets. The Guardian Connection clips around the outside of these connectors, and helps to prevent them from being pulled apart by tensile force.
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