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

    AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE

    K Number: K941603 · Decision Jul 6, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    38
    Applicant Total
    7
    Review Days
    96

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    Basic Information

    Device Name
    AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE
    K Number
    K941603
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4300
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Allergan Medical Optics
    Date Received
    April 1, 1994
    Decision Date
    July 6, 1994
    Product Code
    KYB
    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
    KYB Lens, Guide, Intraocular

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    K924235 AMO ELITE
    K911998 MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM
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