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

    IMPACT MODEL 323 ASPIRATOR

    K Number: K133196 · Decision Mar 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    76
    Applicant Total
    27
    Review Days
    144

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    Basic Information

    Device Name
    IMPACT MODEL 323 ASPIRATOR
    K Number
    K133196
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Impact Instrumentation, Inc.
    Date Received
    October 17, 2013
    Decision Date
    March 10, 2014
    Product Code
    JCX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered

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    Other Clearances by Impact Instrumentation, Inc.

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    K941096 ELECTRIC VACUM PUMP
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