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

    CAPSULAR SHRINKAGE ELECTRODE

    K Number: K991830 · Decision Aug 20, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    93
    Review Days
    84

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    Basic Information

    Device Name
    CAPSULAR SHRINKAGE ELECTRODE
    K Number
    K991830
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Linvatec Corp.
    Date Received
    May 28, 1999
    Decision Date
    August 20, 1999
    Product Code
    JOS
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOS Electrode, Electrosurgical

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