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

    SIMPLICITY DISPOSABLE PEN NEEDLE

    K Number: K002180 · Decision Oct 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    27
    Review Days
    86

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    Basic Information

    Device Name
    SIMPLICITY DISPOSABLE PEN NEEDLE
    K Number
    K002180
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sterling Medivations, Inc.
    Date Received
    July 19, 2000
    Decision Date
    October 13, 2000
    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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    Other Clearances by Sterling Medivations, Inc.

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    K021216 SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS
    K021005 SIMPLICITY EASY ACCESS II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE
    K020990 SIMPLICITY SOFT QD II INFUSION SET FOR INFUSION AND/OR INJECTION OF FLUIDS INTO THE BODY BELOW THE SURFACE OF THE SKIN
    K020912 SIMPLICITY EASY SOFT INFUSION SET
    K020629 SIMPLICITY SIMPLEX SOFT INFUSION SET
    K014062 SIMPLICITY EASY ACCESS INFUSION SET
    K014061 SIMPLICITY STARPLUS SOFT INFUSION SET
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