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

    NO-POKES NEEDLE SAFETY DEVICE

    K Number: K020921 · Decision Jul 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    12
    Review Days
    112

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    Basic Information

    Device Name
    NO-POKES NEEDLE SAFETY DEVICE
    K Number
    K020921
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bemis Mfg. Co.
    Date Received
    March 21, 2002
    Decision Date
    July 11, 2002
    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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