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

    CLINITEX VIS-X ASPIRATING ACCESSORY

    K Number: K780852 · Decision Nov 3, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    86
    Review Days
    165

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    Basic Information

    Device Name
    CLINITEX VIS-X ASPIRATING ACCESSORY
    K Number
    K780852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Varian Assoc., Inc.
    Date Received
    May 22, 1978
    Decision Date
    November 3, 1978
    Product Code
    HKP
    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
    HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered

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