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

    HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE

    K Number: K931072 · Decision Nov 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    23
    Review Days
    618

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    Basic Information

    Device Name
    HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE
    K Number
    K931072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1945
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hgm, Inc.
    Date Received
    March 2, 1993
    Decision Date
    November 10, 1994
    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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