BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OCULOSTAT

    K Number: K981235 · Decision Jul 15, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    103

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    Basic Information

    Device Name
    OCULOSTAT
    K Number
    K981235
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Laser Center Dev. Corp.
    Date Received
    April 3, 1998
    Decision Date
    July 15, 1998
    Product Code
    HNC
    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
    HNC Specula, Ophthalmic

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