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

    EYE-VAC

    K Number: K801231 · Decision Jul 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    14
    Review Days
    55

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    Basic Information

    Device Name
    EYE-VAC
    K Number
    K801231
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Coburn Optical Ind., Inc.
    Date Received
    May 27, 1980
    Decision Date
    July 21, 1980
    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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