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

    PREVANTICS DEVICE SWAB

    K Number: K132380 · Decision Aug 27, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    392

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    Basic Information

    Device Name
    PREVANTICS DEVICE SWAB
    K Number
    K132380
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Professional Disposables International, Inc.
    Date Received
    July 31, 2013
    Decision Date
    August 27, 2014
    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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