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

    D.O.R.C. VFI/VFE SYSTEM

    K Number: K954842 · Decision Apr 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    39
    Applicant Total
    10
    Review Days
    175

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    Basic Information

    Device Name
    D.O.R.C. VFI/VFE SYSTEM
    K Number
    K954842
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.4360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Dutch Ophthalmic USA, Inc.
    Date Received
    October 23, 1995
    Decision Date
    April 15, 1996
    Product Code
    KYG
    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
    KYG Device, Irrigation, Ocular Surgery

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