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

    NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES

    K Number: K944355 · Decision Dec 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    NIPRO BRANDED DISPOSABLE SYRINGES, NEEDLES
    K Number
    K944355
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nissho Corp.
    Date Received
    September 7, 1994
    Decision Date
    December 7, 1994
    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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