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

    ERBE ERBEJET 2 SYSTEM

    K Number: K072404 · Decision Oct 31, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    39
    Review Days
    65

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    Basic Information

    Device Name
    ERBE ERBEJET 2 SYSTEM
    K Number
    K072404
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Erbe USA, Inc.
    Date Received
    August 27, 2007
    Decision Date
    October 31, 2007
    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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