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

    D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM

    K Number: K010082 · Decision Mar 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    10
    Review Days
    61

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    Basic Information

    Device Name
    D.O.R.C. HARMONY TOTAL TTC VITRECTOMY SYSTEM
    K Number
    K010082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dutch Ophthalmic USA, Inc.
    Date Received
    January 10, 2001
    Decision Date
    March 12, 2001
    Product Code
    HQE
    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
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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