BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇴 Norway

    Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml

    K Number: K171805 · Decision Sep 8, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    2
    Review Days
    81

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    Basic Information

    Device Name
    Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
    K Number
    K171805
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conceptomed AS
    Date Received
    June 19, 2017
    Decision Date
    September 8, 2017
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMF Syringe, Piston

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    Other Clearances by Conceptomed AS

    K Number Device Name
    K162057 ConceptoMed Luer-Jack Slip 10ml