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510(k) Data Aggregation

    K Number
    K220165
    Device Name
    Enteral Transition Adaptor
    Manufacturer
    GBUK Group Ltd
    Date Cleared
    2022-10-21

    (274 days)

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

    GBUK Group Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The enteral specific transition connectors are intended to facilitate enteral specific connections between ISO 80369-3 compliant connectors and non-ISO 80369-3 compliant legacy enteral connectors.
    Device Description
    Not Found
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    K Number
    K203633
    Device Name
    Enteral Extension Sets
    Manufacturer
    GBUK Group Ltd
    Date Cleared
    2021-08-19

    (251 days)

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

    GBUK Group Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Enteral Extension Sets with ENFit small bore connectors are intended for enteral feeding, on the order of a physician, to provide a means of delivering enteral nutrition or medication from an enteral feeding syringe through to any feeding tube which will accept a connector for enteral applications.
    Device Description
    Not Found
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