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

    SHARPS CONTAINER, MODEL 039-413

    K Number: K063666 · Decision Jan 25, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    9
    Review Days
    45

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    Basic Information

    Device Name
    SHARPS CONTAINER, MODEL 039-413
    K Number
    K063666
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biodex Medical Systems, Inc.
    Date Received
    December 11, 2006
    Decision Date
    January 25, 2007
    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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