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

    OPHTHALMIC TRICHIASIS PROBE

    K Number: K923629 · Decision Oct 19, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    10
    Applicant Total
    21
    Review Days
    90

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    Basic Information

    Device Name
    OPHTHALMIC TRICHIASIS PROBE
    K Number
    K923629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4170
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mira, Inc.
    Date Received
    July 21, 1992
    Decision Date
    October 19, 1992
    Product Code
    HPS
    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
    HPS Unit, Cryophthalmic

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