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

    ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE

    K Number: K971805 · Decision Jun 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    46
    Review Days
    29

    Basic Information

    Device Name
    ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE
    K Number
    K971805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    AARON MEDICAL INDUSTRIES
    Date Received
    May 15, 1997
    Decision Date
    June 13, 1997
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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