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

    Red2Green Reusable Sharps Container

    K Number: K153363 · Decision Jul 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    1
    Review Days
    249

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    Basic Information

    Device Name
    Red2Green Reusable Sharps Container
    K Number
    K153363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Triumvirate Environmental, Inc.
    Date Received
    November 20, 2015
    Decision Date
    July 26, 2016
    Product Code
    MMK
    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
    MMK Container, Sharps

    Similar 510(k) Clearances

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