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

    HELIX HYDRO-JET

    K Number: K012464 · Decision Oct 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    HELIX HYDRO-JET
    K Number
    K012464
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Andreas Pein Medizintechnik GmbH
    Date Received
    August 1, 2001
    Decision Date
    October 10, 2001
    Product Code
    FQH
    Advisory Committee
    General Hospital
    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
    FQH Lavage, Jet

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