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

    SKIASCOPIC RACKS

    K Number: K844364 · Decision Jan 2, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    50

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    Basic Information

    Device Name
    SKIASCOPIC RACKS
    K Number
    K844364
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1750
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Luneau Laboratories
    Date Received
    November 13, 1984
    Decision Date
    January 2, 1985
    Product Code
    HMH
    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
    HMH Rack, Skiascopic

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    Other Clearances by Luneau Laboratories

    K Number Device Name
    K850068 LUNE AU CURETTES
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    K844362 OPHTHALMIC CHAIR
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