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

    B-D PEN ULTRA

    K Number: K981797 · Decision Jun 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    632
    Review Days
    22

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    Basic Information

    Device Name
    B-D PEN ULTRA
    K Number
    K981797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    May 21, 1998
    Decision Date
    June 12, 1998
    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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