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

    SHARPS-TAINER SMALL OPENING

    K Number: K942903 · Decision Sep 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    5
    Review Days
    144

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    Basic Information

    Device Name
    SHARPS-TAINER SMALL OPENING
    K Number
    K942903
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Winfield Co., Inc.
    Date Received
    April 28, 1994
    Decision Date
    September 19, 1994
    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 Winfield Co., Inc.

    K Number Device Name
    K942902 SHARPS-TAINER SMALL OPENING W/NEEDLE REMOVER
    K942901 SHARPS-TAINER LARGE OPENING
    K891855 WINFIELD LATEX EXAMINATION GLOVES
    K802803 CONVALESCENT RECLINER