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

    WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM

    K Number: K963653 · Decision Jun 11, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    67
    Registration Numbers
    67
    Same Product Code
    52
    Applicant Total
    27
    Review Days
    272

    Basic Information

    Device Name
    WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
    K Number
    K963653
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4120
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    WALLACH SURGICAL DEVICES, INC.
    Date Received
    September 12, 1996
    Decision Date
    June 11, 1997
    Product Code
    HGI
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGI Electrocautery, Gynecologic (And Accessories)

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