BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    U Deliver Bolink ENFit Enteral Feeding Sets

    K Number: K190310 · Decision May 31, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    49
    Applicant Total
    2
    Review Days
    108

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    Basic Information

    Device Name
    U Deliver Bolink ENFit Enteral Feeding Sets
    K Number
    K190310
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    U Deliver Medical, LLC
    Date Received
    February 12, 2019
    Decision Date
    May 31, 2019
    Product Code
    PIF
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PIF Gastrointestinal Tubes With Enteral Specific Connectors

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    Other Clearances by U Deliver Medical, LLC

    K Number Device Name
    K170555 U Deliver Bolink ENFit Enteral Feeding Sets