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

    BIOMICROSCOPY CONTACT LENS

    K Number: K813313 · Decision Mar 1, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    3
    Review Days
    97

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    Basic Information

    Device Name
    BIOMICROSCOPY CONTACT LENS
    K Number
    K813313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Design Research Assoc., Inc.
    Date Received
    November 24, 1981
    Decision Date
    March 1, 1982
    Product Code
    HJO
    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
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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    Other Clearances by Design Research Assoc., Inc.

    K Number Device Name
    K813315 CALIPER-OPTHALMIC
    K813314 NLD IMPLANT SET