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

    360 DEGREE FIXATION LIGHT

    K Number: K933739 · Decision Mar 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    223

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    Basic Information

    Device Name
    360 DEGREE FIXATION LIGHT
    K Number
    K933739
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1290
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Varitronics
    Date Received
    August 3, 1993
    Decision Date
    March 14, 1994
    Product Code
    HPL
    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
    HPL Device, Fixation, Ac-Powered, Ophthalmic

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