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

    IRRIGATION/ASPIRATION KIT

    K Number: K830385 · Decision Apr 5, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    10
    Review Days
    60

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    Basic Information

    Device Name
    IRRIGATION/ASPIRATION KIT
    K Number
    K830385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Vxtra Corp.
    Date Received
    February 4, 1983
    Decision Date
    April 5, 1983
    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 Vxtra Corp.

    K Number Device Name
    K832938 OCUTOME PARATUBING SET
    K832980 VXTRA OCUTOME KIT
    K831266 MICROSURGICAL KNIFE
    K830379 PHAKO KIT
    K812620 ADJUSTABLE MICROSURGICAL KNIFE
    K812526 MICRO BLADE II
    K812160 MICROSURGICAL BLADE
    K800557 DISPOSABLE PRE-GELLED ELECTROSURGICAL
    K792436 VXTRA BACK PACK EKG ELECTRODE CAT. NO.