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

    VANGUARD REPROCESSED PHACOEMULSIFICATION

    K Number: K012698 · Decision Nov 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    33
    Review Days
    87

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    Basic Information

    Device Name
    VANGUARD REPROCESSED PHACOEMULSIFICATION
    K Number
    K012698
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vanguard Medical Concepts, Inc.
    Date Received
    August 14, 2001
    Decision Date
    November 9, 2001
    Product Code
    NKX
    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
    NKX Needle, Phacoemulsification, Reprocessed

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