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

    SITESCRUB IPA DEVICE

    K Number: K112791 · Decision Feb 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    24
    Applicant Total
    9
    Review Days
    151

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    Basic Information

    Device Name
    SITESCRUB IPA DEVICE
    K Number
    K112791
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    C. R. Bard
    Date Received
    September 26, 2011
    Decision Date
    February 24, 2012
    Product Code
    LKB
    Advisory Committee
    Unknown
    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
    LKB Pad, Alcohol, Device Disinfectant

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