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

    REPROCESSED PHACOEMUISIFICATION TIPS

    K Number: K050518 · Decision Sep 23, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    11
    Review Days
    206

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    Basic Information

    Device Name
    REPROCESSED PHACOEMUISIFICATION TIPS
    K Number
    K050518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alliance Medical, Inc.
    Date Received
    March 1, 2005
    Decision Date
    September 23, 2005
    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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