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

    INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR

    K Number: K972506 · Decision Oct 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
    K Number
    K972506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1945
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Infinitech, Inc.
    Date Received
    July 3, 1997
    Decision Date
    October 1, 1997
    Product Code
    HJM
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HJM Transilluminator, Ac-Powered

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