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

    MC6A

    K Number: K050735 · Decision May 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    18
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    MC6A
    K Number
    K050735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Macan Engineering Co.
    Date Received
    March 21, 2005
    Decision Date
    May 23, 2005
    Product Code
    EKZ
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EKZ Unit, Electrosurgical, And Accessories, Dental

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