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

    ABS BLOWER, ABS NOZZLE, MODEL 1001

    K Number: K092801 · Decision May 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    616

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    Basic Information

    Device Name
    ABS BLOWER, ABS NOZZLE, MODEL 1001
    K Number
    K092801
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nimbic Systems, LLC
    Date Received
    September 11, 2009
    Decision Date
    May 20, 2011
    Product Code
    ORC
    Advisory Committee
    General, Plastic Surgery
    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
    ORC Air Filter Portable Apparatus

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