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

    CATAREX/ULTRASONICS KIT

    K Number: K840181 · Decision Oct 5, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    3
    Review Days
    262

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    Basic Information

    Device Name
    CATAREX/ULTRASONICS KIT
    K Number
    K840181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Calliope Corp.
    Date Received
    January 17, 1984
    Decision Date
    October 5, 1984
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by Calliope Corp.

    K Number Device Name
    K840063 CATAREX VITRECUTTER I/A DISPOS. CUT
    K832446 CATAREX DIAP. EXTRACAPSULAR CATARACT