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

    MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881

    K Number: K031799 · Decision Nov 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    155

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    Basic Information

    Device Name
    MIELE DENTAL THERMAL DISINFECTOR, MODEL G7881
    K Number
    K031799
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.6991
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Miele, Inc.
    Date Received
    June 10, 2003
    Decision Date
    November 12, 2003
    Product Code
    LDS
    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
    LDS Device, Pasteurization, Hot Water

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