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

    OAK RIDGE PRODUCTS SHARP CONTAINER

    K Number: K130281 · Decision Jun 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    3
    Review Days
    136

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    Basic Information

    Device Name
    OAK RIDGE PRODUCTS SHARP CONTAINER
    K Number
    K130281
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oak Ridge Products, LLC
    Date Received
    February 5, 2013
    Decision Date
    June 21, 2013
    Product Code
    MMK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MMK Container, Sharps

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    Other Clearances by Oak Ridge Products, LLC

    K Number Device Name
    K161180 Oak Ridge Products Sharps Containers
    K141759 OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS