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

    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

    K Number: K000768 · Decision Apr 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    18
    Applicant Total
    27
    Review Days
    33

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    Basic Information

    Device Name
    WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
    K Number
    K000768
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4920
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wallach Surgical Devices, Inc.
    Date Received
    March 9, 2000
    Decision Date
    April 11, 2000
    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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