BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT

    K Number: K972867 · Decision Oct 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    19
    Review Days
    81

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    Basic Information

    Device Name
    CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
    K Number
    K972867
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.1850
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rocket Medical Plc
    Date Received
    August 4, 1997
    Decision Date
    October 24, 1997
    Product Code
    ICX
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ICX Aniline

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