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

    SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE

    K Number: K912739 · Decision Aug 28, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    30
    Review Days
    68

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    Basic Information

    Device Name
    SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
    K Number
    K912739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Site Microsurgical Systems, Inc.
    Date Received
    June 21, 1991
    Decision Date
    August 28, 1991
    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
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    K921135 IOLAB POWER I.V. POLE
    K920582 180 TIP, 1/A HANDPIECE .3MM END OPENING FOR OPHT.
    K912902 PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
    K910980 SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
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    K904151 SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
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