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

    MODIFIED SITE TXR SYSTEMS

    K Number: K925828 · Decision Feb 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    30
    Review Days
    457

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    Basic Information

    Device Name
    MODIFIED SITE TXR SYSTEMS
    K Number
    K925828
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Site Microsurgical Systems, Inc.
    Date Received
    November 16, 1992
    Decision Date
    February 16, 1994
    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 Site Microsurgical Systems, Inc.

    K Number Device Name
    K925921 MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
    K931866 SITE'S CD II PHACOEMULSIFICATION HANDPIECE
    K921135 IOLAB POWER I.V. POLE
    K920582 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
    K912902 PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
    K912739 SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
    K910980 SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
    K905620 MODIFIED SITE PERISTALTIC FOOTSWITCH
    K904183 SITE PHACOEMULSIFICATION HANDPIECE
    K904151 SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
    Search all 30 clearances from Site Microsurgical Systems, Inc. →