BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PHAKOSYSTEMS MODEL CES 4100

    K Number: K851674 · Decision Aug 5, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    5
    Review Days
    104

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    Basic Information

    Device Name
    PHAKOSYSTEMS MODEL CES 4100
    K Number
    K851674
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Phakosystems, Inc.
    Date Received
    April 23, 1985
    Decision Date
    August 5, 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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    Other Clearances by Phakosystems, Inc.

    K Number Device Name
    K880081 VISION CARE/PHAKOSYSTEMS ECHOPACH
    K871938 VISION CARE/PHAKOSYSTEMS ECHORULE
    K860236 PHAKOSYSTEMS CT-100 CAUTERY MODULE
    K830871 PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION