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

    MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE

    K Number: K880256 · Decision Apr 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    78
    Review Days
    85

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    Basic Information

    Device Name
    MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
    K Number
    K880256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Sharplan Lasers, Inc.
    Date Received
    January 20, 1988
    Decision Date
    April 14, 1988
    Product Code
    LNK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LNK Laser For Gastro-Urology Use

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