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

    INFINITY MICRO IRRIGATOR

    K Number: K924052 · Decision Dec 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    133

    Basic Information

    Device Name
    INFINITY MICRO IRRIGATOR
    K Number
    K924052
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    INFINITY SURGICAL TECHNOLOGY, INC.
    Date Received
    August 12, 1992
    Decision Date
    December 23, 1992
    Product Code
    KYG
    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
    KYG Device, Irrigation, Ocular Surgery

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