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

    BEC SHROUDED PLASTIC CANNULA

    K Number: K961328 · Decision May 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    20
    Review Days
    52

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    Basic Information

    Device Name
    BEC SHROUDED PLASTIC CANNULA
    K Number
    K961328
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biological & Environmental Control Laboratories
    Date Received
    April 8, 1996
    Decision Date
    May 30, 1996
    Product Code
    FMI
    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
    FMI Needle, Hypodermic, Single Lumen

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