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

    OPHTHALMIC LIGHT PIPE PICK

    K Number: K875195 · Decision Mar 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    44
    Applicant Total
    8
    Review Days
    81

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    Basic Information

    Device Name
    OPHTHALMIC LIGHT PIPE PICK
    K Number
    K875195
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Trek Medical Products, Inc.
    Date Received
    December 17, 1987
    Decision Date
    March 7, 1988
    Product Code
    FST
    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
    FST Light, Surgical, Fiberoptic

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