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

    ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS

    K Number: K854225 · Decision Dec 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    7
    Review Days
    70

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    Basic Information

    Device Name
    ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
    K Number
    K854225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Advanced Medical Technology, Inc.
    Date Received
    October 18, 1985
    Decision Date
    December 27, 1985
    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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