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

    Oak Ridge Products Sharps Containers

    K Number: K161180 · Decision Jun 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    3
    Review Days
    43

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    Basic Information

    Device Name
    Oak Ridge Products Sharps Containers
    K Number
    K161180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oak Ridge Products, LLC
    Date Received
    April 27, 2016
    Decision Date
    June 9, 2016
    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

    Similar 510(k) Clearances

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    Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong

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    Other Clearances by Oak Ridge Products, LLC

    K Number Device Name
    K141759 OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS
    K130281 OAK RIDGE PRODUCTS SHARP CONTAINER